Trial Outcomes & Findings for Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer (NCT NCT03301350)
NCT ID: NCT03301350
Last Updated: 2023-02-01
Results Overview
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. pCR will be assessed according to RECIST 1.1 criteria. The point estimate of the primary efficacy endpoint pCR and its exact 95% confidence intervals (CI) will be calculated. In evaluating pCR, subjects with missing data will be considered non-responders.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2023-02-01
Participant Flow
29 participants were assigned, but only 28 participants started treatment
Participant milestones
| Measure |
Neoadjuvant Chemotherapy
Participants receive Paclitaxel and Carboplatin AUC=2 on days 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks).
There is a one week break between the end of cycle 4 and the beginning of cycle 5.
Participants receive Doxorubicin and Cyclophosphamide on day 1 of cycles 5, 6, 7, 8 (every 2 weeks). Participants also receive Pegfilgrastim, filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks)
Participants undergo surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Neoadjuvant Chemotherapy
Participants receive Paclitaxel and Carboplatin AUC=2 on days 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks).
There is a one week break between the end of cycle 4 and the beginning of cycle 5.
Participants receive Doxorubicin and Cyclophosphamide on day 1 of cycles 5, 6, 7, 8 (every 2 weeks). Participants also receive Pegfilgrastim, filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks)
Participants undergo surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Pt withdrawn per DSMC request
|
1
|
|
Overall Study
completed all chemo cycles, however died prior to definitive surgery
|
1
|
|
Overall Study
no detail provided
|
1
|
Baseline Characteristics
Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Chemotherapy
n=29 Participants
Paclitaxel (cycles 1-4):
Doxorubicin, Cyclophosphamide, and Pegfilgrastim (cycles 5-8):
Surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
|
|---|---|
|
Age, Customized
30-39
|
5 Participants
n=5 Participants
|
|
Age, Customized
40-49
|
7 Participants
n=5 Participants
|
|
Age, Customized
50-59
|
12 Participants
n=5 Participants
|
|
Age, Customized
60-69
|
3 Participants
n=5 Participants
|
|
Age, Customized
70-79
|
1 Participants
n=5 Participants
|
|
Age, Customized
80-89
|
1 Participants
n=5 Participants
|
|
Age, Customized
Unknown
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: 4 participants did not reach the timepoint at which pCR was measured, therefore are not counted in the analysis
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. pCR will be assessed according to RECIST 1.1 criteria. The point estimate of the primary efficacy endpoint pCR and its exact 95% confidence intervals (CI) will be calculated. In evaluating pCR, subjects with missing data will be considered non-responders.
Outcome measures
| Measure |
Neoadjuvant Chemotherapy
n=24 Participants
Participants receive Paclitaxel and Carboplatin AUC=2 on days 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks).
There is a one week break between the end of cycle 4 and the beginning of cycle 5.
Participants receive Doxorubicin and Cyclophosphamide on day 1 of cycles 5, 6, 7, 8 (every 2 weeks). Participants also receive Pegfilgrastim, filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks)
Participants undergo surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
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|---|---|
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Number and Percentage of Participants With Pathologic Complete Response (pCR) Rate
|
8 Participants
|
SECONDARY outcome
Timeframe: Week 12 to week 18 to account for possible delaysTo evaluate the number of cycles low dose weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the number of cycles of chemotherapy administered.
Outcome measures
| Measure |
Neoadjuvant Chemotherapy
n=28 Participants
Participants receive Paclitaxel and Carboplatin AUC=2 on days 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks).
There is a one week break between the end of cycle 4 and the beginning of cycle 5.
Participants receive Doxorubicin and Cyclophosphamide on day 1 of cycles 5, 6, 7, 8 (every 2 weeks). Participants also receive Pegfilgrastim, filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks)
Participants undergo surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
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|---|---|
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Number of Cycles of Chemotherapy Administered
4 complete cycles
|
25 Participants
|
|
Number of Cycles of Chemotherapy Administered
Less than 1 cycle
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 12 to week 18 to account for possible delaysPopulation: 2 participants were withdrawn from study prior to completing carbo-paclitaxel; thus, have not been included in this measure
To evaluate the total dose of weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the dose amount of chemotherapy administered.
Outcome measures
| Measure |
Neoadjuvant Chemotherapy
n=26 Participants
Participants receive Paclitaxel and Carboplatin AUC=2 on days 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks).
There is a one week break between the end of cycle 4 and the beginning of cycle 5.
Participants receive Doxorubicin and Cyclophosphamide on day 1 of cycles 5, 6, 7, 8 (every 2 weeks). Participants also receive Pegfilgrastim, filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks)
Participants undergo surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
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|---|---|
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Total Dose of Chemotherapy Administered
Carboplatin dose AUC of 2.0 - full dose
|
285 doses administered
|
|
Total Dose of Chemotherapy Administered
paclitaxel dose: 80 mg/m2 - full dose
|
279 doses administered
|
|
Total Dose of Chemotherapy Administered
Carboplatin reduced dose AUC 1.6
|
15 doses administered
|
|
Total Dose of Chemotherapy Administered
Carboplatin reduced dose AUC 1.5
|
2 doses administered
|
|
Total Dose of Chemotherapy Administered
Paclitaxel - reduced dose
|
23 doses administered
|
SECONDARY outcome
Timeframe: Week 12 to week 18 to account for possible delaysPopulation: 2 participants were withdrawn from study prior to completing carbo-paclitaxel; thus, have not been included in this measure
To evaluate the delays of low dose weekly Carboplatin/Paclitaxel regimen administered. Simple descriptive statistics will be used to describe the delays of chemotherapy administered.
Outcome measures
| Measure |
Neoadjuvant Chemotherapy
n=26 Participants
Participants receive Paclitaxel and Carboplatin AUC=2 on days 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks).
There is a one week break between the end of cycle 4 and the beginning of cycle 5.
Participants receive Doxorubicin and Cyclophosphamide on day 1 of cycles 5, 6, 7, 8 (every 2 weeks). Participants also receive Pegfilgrastim, filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks)
Participants undergo surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
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|---|---|
|
Delays of Administered Chemotherapy
Participants with no delays
|
12 Participants
|
|
Delays of Administered Chemotherapy
Participants with single 1 week delay
|
7 Participants
|
|
Delays of Administered Chemotherapy
Participants with single 2 week delay
|
3 Participants
|
|
Delays of Administered Chemotherapy
Participants with more than 1 delay
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to week 12Count of any treatment-related toxicities from the low dose weekly Carboplatin/Paclitaxel regimen. Will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Outcome measures
| Measure |
Neoadjuvant Chemotherapy
n=28 Participants
Participants receive Paclitaxel and Carboplatin AUC=2 on days 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks).
There is a one week break between the end of cycle 4 and the beginning of cycle 5.
Participants receive Doxorubicin and Cyclophosphamide on day 1 of cycles 5, 6, 7, 8 (every 2 weeks). Participants also receive Pegfilgrastim, filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks)
Participants undergo surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
|
|---|---|
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Number of Treatment-related Toxicities Experienced by Participants
Neutrophil count decreased
|
26 treatment related toxicities
|
|
Number of Treatment-related Toxicities Experienced by Participants
Anemia
|
27 treatment related toxicities
|
|
Number of Treatment-related Toxicities Experienced by Participants
Platelet count decreased
|
22 treatment related toxicities
|
|
Number of Treatment-related Toxicities Experienced by Participants
White blood cells decreased
|
25 treatment related toxicities
|
|
Number of Treatment-related Toxicities Experienced by Participants
ALT increased
|
9 treatment related toxicities
|
|
Number of Treatment-related Toxicities Experienced by Participants
AST increased
|
8 treatment related toxicities
|
|
Number of Treatment-related Toxicities Experienced by Participants
Creatinine increased
|
2 treatment related toxicities
|
|
Number of Treatment-related Toxicities Experienced by Participants
Bilirubin increased
|
1 treatment related toxicities
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 4 participants did not reach the timepoint at which RFS was measured, therefore are not counted in the analysis
To evaluate two-year RFS after treatment with this neoadjuvant regimen. Count of participants without evidence for local-regional or distant relapse, second primary, or death will be reported.
Outcome measures
| Measure |
Neoadjuvant Chemotherapy
n=24 Participants
Participants receive Paclitaxel and Carboplatin AUC=2 on days 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks).
There is a one week break between the end of cycle 4 and the beginning of cycle 5.
Participants receive Doxorubicin and Cyclophosphamide on day 1 of cycles 5, 6, 7, 8 (every 2 weeks). Participants also receive Pegfilgrastim, filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks)
Participants undergo surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
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|---|---|
|
Recurrence-free Survival (RFS)
Deceased, recurrent disease
|
2 Participants
|
|
Recurrence-free Survival (RFS)
No evidence of disease
|
18 Participants
|
|
Recurrence-free Survival (RFS)
Alive, recurrent disease
|
2 Participants
|
|
Recurrence-free Survival (RFS)
Alive, unknown disease status
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 3 participants did not reach the timepoint at which OS was measured, therefore are not counted in the analysis
To evaluate the two-year overall survival after treatment with this neoadjuvant regimen. Count of participants who achieved 2 year OS is reported.
Outcome measures
| Measure |
Neoadjuvant Chemotherapy
n=25 Participants
Participants receive Paclitaxel and Carboplatin AUC=2 on days 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks).
There is a one week break between the end of cycle 4 and the beginning of cycle 5.
Participants receive Doxorubicin and Cyclophosphamide on day 1 of cycles 5, 6, 7, 8 (every 2 weeks). Participants also receive Pegfilgrastim, filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks)
Participants undergo surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
|
|---|---|
|
Overall Survival (OS)
2 year survival
|
22 Participants
|
|
Overall Survival (OS)
Deceased
|
3 Participants
|
Adverse Events
Neoadjuvant Chemotherapy
Serious events: 17 serious events
Other events: 10 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Neoadjuvant Chemotherapy
n=10 participants at risk；n=28 participants at risk
Regimen A (cycles 1-4):
Paclitaxel 80 mg/m2; administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Carboplatin AUC=2 (dose calculation by determining creatine clearance with Cockroft Gault using adjusted body weight); administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks)
Regimen B (cycles 5-8):
Doxorubicin 60 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Cyclophosphamide 600 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Pegfilgrastim (for use on Doxorubicin/Cyclophosphamide cycles only), filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks)
There is a one week break between the end of cycle 4 and the beginning of cycle 5.
Regimen C:
Surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
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|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
17.9%
5/28 • Number of events 5 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
4/28 • Number of events 4 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Cardiac disorders
Atrial fibrilation
|
7.1%
2/28 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Cardiac disorders
Sinus tachycardia
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Abdomincal pain
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Mucositis oral
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
General disorders
Chills
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
General disorders
Fatigue
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Hepatobiliary disorders
Cholecystitis
|
7.1%
2/28 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Lung infection
|
7.1%
2/28 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Otitis media
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
Neutrophil count decreased
|
53.6%
15/28 • Number of events 15 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
platelet count decreased
|
7.1%
2/28 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
White blood cell decreased
|
7.1%
2/28 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.6%
1/28 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Vascular disorders
Thromboembolic event
|
7.1%
2/28 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
Other adverse events
| Measure |
Neoadjuvant Chemotherapy
n=10 participants at risk；n=28 participants at risk
Regimen A (cycles 1-4):
Paclitaxel 80 mg/m2; administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks) Carboplatin AUC=2 (dose calculation by determining creatine clearance with Cockroft Gault using adjusted body weight); administer intravenously on day 1, 8, 15 of cycles 1, 2, 3, 4 (every 3 weeks)
Regimen B (cycles 5-8):
Doxorubicin 60 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Cyclophosphamide 600 mg/m2; administer intravenously on day 1 of cycles 5, 6, 7, 8 (every 2 weeks) Pegfilgrastim (for use on Doxorubicin/Cyclophosphamide cycles only), filgrastim, or biosimilar support on day 2 - 3 of cycles 5, 6, 7, 8 (every 2 weeks)
There is a one week break between the end of cycle 4 and the beginning of cycle 5.
Regimen C:
Surgical intervention for management of breast cancer diagnosis; procedure and timing as determined by surgical team.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
10/10 • Number of events 39 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
Neutrophil count decreased
|
100.0%
10/10 • Number of events 33 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
Platelet count decreased
|
80.0%
8/10 • Number of events 18 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
White blood cell decreased
|
100.0%
10/10 • Number of events 53 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Nausea
|
80.0%
8/10 • Number of events 8 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Constipation
|
70.0%
7/10 • Number of events 7 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Diarrhea
|
60.0%
6/10 • Number of events 7 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Dyspepsia
|
30.0%
3/10 • Number of events 3 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Mucositis oral
|
30.0%
3/10 • Number of events 3 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • Number of events 3 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
2/10 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Bloating
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Enterocolitis
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Fecal incontinence
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Dysgeusia
|
80.0%
8/10 • Number of events 8 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Stomach pain
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
Aspartate aminotransferase increased
|
60.0%
6/10 • Number of events 7 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
5/10 • Number of events 5 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
90.0%
9/10 • Number of events 9 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
Creatinine increased
|
20.0%
2/10 • Number of events 3 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
Weight gain
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
Weight loss
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Investigations
INR increased
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
General disorders
Fatigue
|
100.0%
10/10 • Number of events 11 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
General disorders
Fever
|
50.0%
5/10 • Number of events 5 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
General disorders
Chills
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
General disorders
Edema limbs
|
20.0%
2/10 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
General disorders
Localized edema
|
30.0%
3/10 • Number of events 3 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
General disorders
Edema face
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
General disorders
Generalized edema
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
70.0%
7/10 • Number of events 7 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Nervous system disorders
Headache
|
50.0%
5/10 • Number of events 5 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Nervous system disorders
Dizziness
|
50.0%
5/10 • Number of events 5 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Nervous system disorders
Paresthesia
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.0%
3/10 • Number of events 3 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
60.0%
6/10 • Number of events 6 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
5/10 • Number of events 5 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
5/10 • Number of events 5 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
20.0%
2/10 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
4/10 • Number of events 4 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
20.0%
2/10 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.0%
4/10 • Number of events 4 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
40.0%
4/10 • Number of events 4 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
2/10 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
40.0%
4/10 • Number of events 4 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
2/10 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
30.0%
3/10 • Number of events 3 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
40.0%
4/10 • Number of events 4 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
2/10 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
5/10 • Number of events 5 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
5/10 • Number of events 5 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
20.0%
2/10 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Vascular disorders
Hot flashes
|
50.0%
5/10 • Number of events 5 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Vascular disorders
Hypotension
|
30.0%
3/10 • Number of events 3 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Vascular disorders
Thromboembolic event
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Vascular disorders
Hematoma
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Folliculitis
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
2/10 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Lung infection
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Nail infection
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Thrush
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Conjunctivitis infective
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Enterocolitis infectious
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Eye infection
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Infections and infestations
Upper respiratory infection
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Eye disorders
Blurred vision
|
30.0%
3/10 • Number of events 3 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Eye disorders
Dry eye
|
20.0%
2/10 • Number of events 2 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Eye disorders
Conjuntivitis infective
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Renal and urinary disorders
Dysuria
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Renal and urinary disorders
Hemoglobinuria
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Reproductive system and breast disorders
Breast pain
|
30.0%
3/10 • Number of events 3 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Reproductive system and breast disorders
Menorrhagia
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Immune system disorders
Allergic reaction
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
|
Gastrointestinal disorders
Bilirubin increased
|
10.0%
1/10 • Number of events 1 • 2 years from starting study treatment
Other (Not Including Serious) Adverse Events were not collected/monitored at collaborating site for 18 of the participants; therefore, there is no data to report and the number assessed is most accurately represented as 10 at risk for Other Adverse Events.
|
Additional Information
Kari Wisinski, MD
University of Wisconsin Carbone Cancer Center
Phone: 608-262-2876
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place