Trial Outcomes & Findings for MARGetuximab Or Trastuzumab (MARGOT) (NCT NCT04425018)
NCT ID: NCT04425018
Last Updated: 2025-11-18
Results Overview
Compare the percentage of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
174 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-11-18
Participant Flow
Participant milestones
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
|
Overall Study
STARTED
|
118
|
56
|
|
Overall Study
COMPLETED
|
117
|
54
|
Reasons for withdrawal
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
MARGetuximab Or Trastuzumab (MARGOT)
Baseline characteristics by cohort
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
n=117 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
n=54 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.1 Years
n=202 Participants
|
55.1 Years
n=283 Participants
|
52.6 Years
n=120 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=202 Participants
|
54 Participants
n=283 Participants
|
171 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=202 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=202 Participants
|
6 Participants
n=283 Participants
|
22 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=202 Participants
|
46 Participants
n=283 Participants
|
145 Participants
n=120 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
4 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
90 Participants
n=202 Participants
|
42 Participants
n=283 Participants
|
132 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
13 Participants
n=202 Participants
|
4 Participants
n=283 Participants
|
17 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
5 Participants
n=202 Participants
|
2 Participants
n=283 Participants
|
7 Participants
n=120 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
9 Participants
n=202 Participants
|
6 Participants
n=283 Participants
|
15 Participants
n=120 Participants
|
|
Clinical stage of primary breast cancer
Stage II
|
100 Participants
n=202 Participants
|
46 Participants
n=283 Participants
|
146 Participants
n=120 Participants
|
|
Clinical stage of primary breast cancer
Stage III
|
17 Participants
n=202 Participants
|
8 Participants
n=283 Participants
|
25 Participants
n=120 Participants
|
|
Hormone receptor status of primary breast cancer
Positive (ER >= 1% or PR >= 1%)
|
74 Participants
n=202 Participants
|
37 Participants
n=283 Participants
|
111 Participants
n=120 Participants
|
|
Hormone receptor status of primary breast cancer
Negative (ER < 1% and PR < 1%)
|
43 Participants
n=202 Participants
|
17 Participants
n=283 Participants
|
60 Participants
n=120 Participants
|
|
CD16A Genotype
FF
|
50 Participants
n=202 Participants
|
30 Participants
n=283 Participants
|
80 Participants
n=120 Participants
|
|
CD16A Genotype
FV
|
67 Participants
n=202 Participants
|
24 Participants
n=283 Participants
|
91 Participants
n=120 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Subjects who received at least one dose of their assigned treatment and were deemed eligible for the study based on all listed inclusion and exclusion criteria. Note: One subject in "Paclitaxel + Pertuzumab + Margetuximab" arm was excluded from pCR analysis because they were diagnosed with inflammatory breast cancer (IBC) after starting treatment, and IBC was an exclusion criteria of the study (this reduced the number of analyzed participants in this arm from 117 to 116).
Compare the percentage of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review.
Outcome measures
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
n=116 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
n=54 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
|---|---|---|
|
Pathologic Complete Response (pCR)
pCR Responder
|
65 Participants
|
24 Participants
|
|
Pathologic Complete Response (pCR)
pCR Non-Responder
|
51 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Hormone receptor positive (HR+) subjects with hormone receptor positive (HR+) primary breast cancers who received at least one dose of their assigned treatment and were deemed eligible for the study based on all listed inclusion and exclusion criteria.
In hormone receptor positive (HR+) patients, compare the rate of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review.
Outcome measures
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
n=74 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
n=37 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
|---|---|---|
|
Rate of Pathologic Complete Response in Hormone Receptor Positive (HR+) Subjects
pCR Non-Responder
|
34 Participants
|
24 Participants
|
|
Rate of Pathologic Complete Response in Hormone Receptor Positive (HR+) Subjects
pCR Responder
|
40 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: HR- subjects who received at least one dose of their assigned treatment and were deemed eligible for the study based on all listed inclusion and exclusion criteria. Note: One subject in "Paclitaxel + Pertuzumab + Margetuximab" arm was excluded from pCR analysis because they were diagnosed with inflammatory breast cancer (IBC) after starting treatment, and IBC was an exclusion criteria of the study (this reduced the number of analyzed participants in this arm from 43 to 42).
In hormone receptor negative (HR-) patients, compare the rate of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review.
Outcome measures
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
n=42 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
n=17 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
|---|---|---|
|
Rate of Pathologic Complete Response in Hormone Receptor Negative (HR-) Subjects
pCR Non-Responder
|
17 Participants
|
6 Participants
|
|
Rate of Pathologic Complete Response in Hormone Receptor Negative (HR-) Subjects
pCR Responder
|
25 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Subjects who received at least one dose of their assigned treatment and were deemed eligible for the study based on all listed inclusion and exclusion criteria. Note: One subject in "Paclitaxel + Pertuzumab + Margetuximab" arm was excluded from pCR analysis because they were diagnosed with inflammatory breast cancer (IBC) after starting treatment, and IBC was an exclusion criteria of the study (this reduced the number of analyzed participants in this arm from 117 to 116).
Assess Residual Cancer Burden (RCB) scores in patients treated with TMP or THP, reported using the Residual Cancer Burden calculator from M.D Anderson. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review.
Outcome measures
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
n=116 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
n=54 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
|---|---|---|
|
Residual Cancer Burden (RCB) Scores
RCB-0 (no residual disease)
|
65 Participants
|
24 Participants
|
|
Residual Cancer Burden (RCB) Scores
RCB-I (minimal residual disease)
|
8 Participants
|
7 Participants
|
|
Residual Cancer Burden (RCB) Scores
RCB-II (moderate residual disease)
|
29 Participants
|
15 Participants
|
|
Residual Cancer Burden (RCB) Scores
RCB-III (extensive residual disease)
|
2 Participants
|
1 Participants
|
|
Residual Cancer Burden (RCB) Scores
Received additional neoadjuvant therapy
|
10 Participants
|
7 Participants
|
|
Residual Cancer Burden (RCB) Scores
Surgery not performed
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Hormone receptor positive (HR+) subjects who received at least one dose of their assigned treatment and were deemed eligible for the study based on all listed inclusion and exclusion criteria.
Among hormone receptor positive (HR+) patients, assess Residual Cancer Burden (RCB) scores in patients treated with TMP or THP, reported using the Residual Cancer Burden calculator from M.D Anderson.
Outcome measures
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
n=74 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
n=37 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
|---|---|---|
|
Residual Cancer Burden (RCB) Scores in Hormone Receptor Positive (HR+) Subjects
RCB-I (minimal residual disease)
|
7 Participants
|
4 Participants
|
|
Residual Cancer Burden (RCB) Scores in Hormone Receptor Positive (HR+) Subjects
RCB-II (moderate residual disease)
|
21 Participants
|
13 Participants
|
|
Residual Cancer Burden (RCB) Scores in Hormone Receptor Positive (HR+) Subjects
RCB-III (extensive residual disease)
|
1 Participants
|
1 Participants
|
|
Residual Cancer Burden (RCB) Scores in Hormone Receptor Positive (HR+) Subjects
Received additional neoadjuvant therapy
|
5 Participants
|
6 Participants
|
|
Residual Cancer Burden (RCB) Scores in Hormone Receptor Positive (HR+) Subjects
Surgery not performed
|
0 Participants
|
0 Participants
|
|
Residual Cancer Burden (RCB) Scores in Hormone Receptor Positive (HR+) Subjects
RCB-0 (no residual disease)
|
40 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: HR- subjects who received at least one dose of their assigned treatment and were deemed eligible for the study based on all listed inclusion and exclusion criteria. Note: One subject in "Paclitaxel + Pertuzumab + Margetuximab" arm was excluded from pCR analysis because they were diagnosed with inflammatory breast cancer (IBC) after starting treatment, and IBC was an exclusion criteria of the study (this reduced the number of analyzed participants in this arm from 43 to 42).
Among hormone receptor negative (HR-) subjects, assess Residual Cancer Burden (RCB) scores in patients treated with TMP or THP, reported using the Residual Cancer Burden calculator from M.D Anderson. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review.
Outcome measures
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
n=42 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
n=17 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
|---|---|---|
|
Residual Cancer Burden (RCB) Scores in Hormone Receptor Negative (HR-) Subjects
RCB-0 (no residual disease)
|
25 Participants
|
11 Participants
|
|
Residual Cancer Burden (RCB) Scores in Hormone Receptor Negative (HR-) Subjects
RCB-I (minimal residual disease)
|
1 Participants
|
3 Participants
|
|
Residual Cancer Burden (RCB) Scores in Hormone Receptor Negative (HR-) Subjects
RCB-II (moderate residual disease)
|
8 Participants
|
2 Participants
|
|
Residual Cancer Burden (RCB) Scores in Hormone Receptor Negative (HR-) Subjects
RCB-III (extensive residual disease)
|
1 Participants
|
0 Participants
|
|
Residual Cancer Burden (RCB) Scores in Hormone Receptor Negative (HR-) Subjects
Received additional neoadjuvant therapy
|
5 Participants
|
1 Participants
|
|
Residual Cancer Burden (RCB) Scores in Hormone Receptor Negative (HR-) Subjects
Surgery not performed
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first treatment to 21 daysPopulation: All subjects treated at least one dose of TMP (Paclitaxel/Margetuximab/Pertuzumab).
Among the subjects treated with TMP (Paclitaxel/Margetuximab/Pertuzumab), report the number of subjects with dose-limiting toxicities (DLTs) during the first 21 days of treatment, where 21 days equals one cycle of treatment. DLTs are defined in Section 5.4 of the protocol, with the specified toxicities and lab values categorized and graded according to CTCAE v5.0.
Outcome measures
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
n=117 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
|---|---|---|
|
Dose-limiting Toxicities (DLTs) in theTMP Arm (Paclitaxel/Margetuximab/Pertuzumab) During the First 21 Days of Treatment
Dose-limiting toxicity observed
|
2 Participants
|
—
|
|
Dose-limiting Toxicities (DLTs) in theTMP Arm (Paclitaxel/Margetuximab/Pertuzumab) During the First 21 Days of Treatment
Dose-limiting toxicity not observed
|
115 Participants
|
—
|
SECONDARY outcome
Timeframe: Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.Population: All subjects who received at least one dose of study treatment
Maximum grade of all treatment-related adverse events (TRAEs) according to CTCAE v5.0 during neoadjuvant treatment, recorded per patient per arm. Subjects with no TRAEs reported (Grade 0) and Grade 1 adverse events are combined into a single category because only adverse events of Grade 2 or more were consistently reported.
Outcome measures
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
n=117 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
n=54 Participants
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
|---|---|---|
|
Maximum Grade of All Treatment-related Adverse Events During Neoadjuvant Treatment
Grade 5 (fatal)
|
0 Participants
|
0 Participants
|
|
Maximum Grade of All Treatment-related Adverse Events During Neoadjuvant Treatment
Grade 0 (no toxicities reported) or 1 (mild)
|
23 Participants
|
16 Participants
|
|
Maximum Grade of All Treatment-related Adverse Events During Neoadjuvant Treatment
Grade 2 (moderate)
|
68 Participants
|
24 Participants
|
|
Maximum Grade of All Treatment-related Adverse Events During Neoadjuvant Treatment
Grade 3 (severe)
|
25 Participants
|
14 Participants
|
|
Maximum Grade of All Treatment-related Adverse Events During Neoadjuvant Treatment
Grade 4 (life threatening)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first treatment to 12 weeksPatient-reported outcomes for symptoms and quality of life (both physical and mental health) during neoadjuvant TMP and THP
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to occurrence invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for EFS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence ror death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: patients who undergo surgery for breast cancer as the interval from the time of surgery until the occurrence of invasive local/regional recurrence distant recurrence or death from breast cancer or up to 10 yearsThe distribution of the survival function and cumulative incidence function for RFI summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 10 years from definitive surgery.The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 10 years from definitive surgery.The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 10 years from definitive surgery.The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 10 years from definitive surgery.The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 10 years from definitive surgery.The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 10 years from definitive surgery.The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 10 years from definitive surgery.The distribution of the survival function and cumulative incidence function for OS, summarized using the Kaplan Meier product limit estimator and 90% confidence interval (CI) using Greenwood's formula for the standard error
Outcome measures
Outcome data not reported
Adverse Events
Paclitaxel + Pertuzumab + Margetuximab
Serious events: 4 serious events
Other events: 105 other events
Deaths: 1 deaths
Paclitaxel + Pertuzumab + Trastuzumab
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
n=117 participants at risk
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
n=54 participants at risk
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
|---|---|---|
|
Infections and infestations
Catheter related infection
|
0.00%
0/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
Neutrophil count decreased
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
0.00%
0/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Nervous system disorders
Seizure
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
0.00%
0/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
0.00%
0/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
0.00%
0/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
0.00%
0/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Vascular disorders
Thromboembolic event
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
0.00%
0/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
Other adverse events
| Measure |
Paclitaxel + Pertuzumab + Margetuximab
n=117 participants at risk
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Margetuximab via IV, Day 1 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Margetuximab: Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
|
Paclitaxel + Pertuzumab + Trastuzumab
n=54 participants at risk
The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days
* Paclitaxel- via IV, Day 1,8,15 of each cycle
* Pertuzumab via IV, Day 1 of each cycle
* Trastuzumab via IV, Day 1 of each cycle
Paclitaxel: Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
Pertuzumab: Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
Trastuzumab: Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
18.8%
22/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
29.6%
16/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Cardiac disorders
Palpitations
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Cardiac disorders
Sinus bradycardia
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Cardiac disorders
Sinus tachycardia
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Ear and labyrinth disorders
Ear pain
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Ear and labyrinth disorders
Vertigo
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Eye disorders
Blurred vision
|
2.6%
3/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Eye disorders
Dry eye
|
5.1%
6/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Eye disorders
Flashing lights
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Eye disorders
Floaters
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Eye disorders
Vision decreased
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
5/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Belching
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Bloating
|
6.8%
8/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Constipation
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
7.4%
4/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Diarrhea
|
41.0%
48/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
42.6%
23/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Dry mouth
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
9/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
7.4%
4/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Dysphagia
|
10.3%
12/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
9/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
19.7%
23/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Mucositis oral
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
9.3%
5/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Nausea
|
5.1%
6/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
24.1%
13/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Oral pain
|
5.1%
6/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Periodontal disease
|
5.1%
6/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Stomach pain
|
5.1%
6/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
6/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
9.3%
5/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
General disorders
Edema limbs
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
General disorders
Fatigue
|
26.5%
31/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
18.5%
10/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
General disorders
Fever
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
General disorders
Flu like symptoms
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
General disorders
Generalized edema
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
General disorders
Localized edema
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
General disorders
Non-cardiac chest pain
|
4.3%
5/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
General disorders
Pain
|
4.3%
5/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Catheter related infection
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Folliculitis
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Otitis externa
|
2.6%
3/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Papulopustular rash
|
6.8%
8/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Rash pustular
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Sepsis
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Sinusitis
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Skin infection
|
5.1%
6/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Thrush
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Upper respiratory infection
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Urinary tract infection
|
4.3%
5/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Vaginal infection
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Infections and infestations
Wound infection
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Bruising
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
27.4%
32/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Seroma
|
2.6%
3/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
13/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
16.7%
9/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
Alkaline phosphatase increased
|
2.6%
3/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
7.4%
4/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
Aspartate aminotransferase increased
|
6.8%
8/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
14.8%
8/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
Blood bilirubin increased
|
2.6%
3/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
CD4 lymphocytes decreased
|
2.6%
3/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
Creatinine increased
|
8.5%
10/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
Ejection fraction decreased
|
15.4%
18/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
Lymphocyte count decreased
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
11.1%
6/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
Lymphocyte count increased
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
Neutrophil count decreased
|
6.8%
8/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
18.5%
10/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
Weight gain
|
6.8%
8/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
Weight loss
|
6.8%
8/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Investigations
White blood cell decreased
|
6.8%
8/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
13.0%
7/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Anorexia
|
3.4%
4/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
13.0%
7/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.1%
6/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.6%
3/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.6%
3/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.0%
7/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
9.3%
5/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.4%
4/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
5/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
7.4%
4/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
3/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.6%
3/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Nervous system disorders
Dizziness
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Nervous system disorders
Dysgeusia
|
4.3%
5/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
11.1%
6/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Nervous system disorders
Headache
|
6.8%
8/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
11.1%
6/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Nervous system disorders
Memory impairment
|
10.3%
12/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Nervous system disorders
Paresthesia
|
5.1%
6/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
20.4%
11/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
20.4%
11/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.1%
27/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
20.4%
11/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Nervous system disorders
Tremor
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
20.4%
11/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Psychiatric disorders
Anxiety
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Psychiatric disorders
Depression
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Psychiatric disorders
Insomnia
|
6.0%
7/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Psychiatric disorders
Irritability
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Renal and urinary disorders
Dysuria
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Renal and urinary disorders
Glucosuria
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Renal and urinary disorders
Urinary frequency
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Renal and urinary disorders
Urinary incontinence
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Renal and urinary disorders
Urinary tract pain
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Renal and urinary disorders
Urinary urgency
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Reproductive system and breast disorders
Amenorrhea
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Reproductive system and breast disorders
Breast pain
|
6.0%
7/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Reproductive system and breast disorders
Vaginal pain
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
6.0%
7/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
7/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
9.3%
5/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.4%
11/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
9.3%
5/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
20.4%
11/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.1%
6/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.4%
4/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
3.4%
4/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
7.4%
4/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
3.4%
4/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.4%
4/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.8%
29/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
9.3%
5/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.5%
10/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
9.3%
5/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
14.8%
8/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
16.7%
9/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
17.1%
20/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
9.4%
11/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
3.4%
4/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Vascular disorders
Flushing
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
5.6%
3/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Vascular disorders
Hot flashes
|
0.85%
1/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
3.7%
2/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Vascular disorders
Hypertension
|
9.4%
11/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
29.6%
16/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Vascular disorders
Thromboembolic event
|
10.3%
12/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
|
Vascular disorders
Hypotension
|
1.7%
2/117 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
1.9%
1/54 • Time from first dose of neoadjuvant treatment to start of de-escalated MP or HP protocol adjuvant therapy if subject received the de-escalated MP or HP protocol adjuvant therapy, up to 1 year after the last dose of their neoadjuvant treatment.
Regular investigator assessment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place