Trial Outcomes & Findings for Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP] (NCT NCT03747120)
NCT ID: NCT03747120
Last Updated: 2025-06-27
Results Overview
Proportion of subjects without residual invasive cancer in the breast and axilla from randomization to definitive surgery. \- Residual invasive cancer defined based on hematoxylin and eosin evaluation of complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by pathologist assessment.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
138 participants
Primary outcome timeframe
16 weeks from randomization
Results posted on
2025-06-27
Participant Flow
Participant milestones
| Measure |
Arm A: THP
Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
|
Arm B: THP-Pembrolizumab
Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
Arm C: TH-Pembrolizumab
Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
22
|
|
Overall Study
COMPLETED
|
55
|
57
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
2
|
Reasons for withdrawal
| Measure |
Arm A: THP
Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
|
Arm B: THP-Pembrolizumab
Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
Arm C: TH-Pembrolizumab
Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
|---|---|---|---|
|
Overall Study
treatment related toxicity
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
Baseline Characteristics
Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]
Baseline characteristics by cohort
| Measure |
Arm A: THP
n=58 Participants
Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
|
Arm B: THP-Pembrolizumab
n=58 Participants
Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
Arm C: TH-Pembrolizumab
n=22 Participants
Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Age, Continuous
|
53.52 years
n=5 Participants
|
52.24 years
n=7 Participants
|
51.59 years
n=5 Participants
|
52.67 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=5 Participants
|
58 participants
n=7 Participants
|
22 participants
n=5 Participants
|
138 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 16 weeks from randomizationPopulation: Data shown are for the intention-to-treat population, which is defined as any subject who was randomized regardless of treatment completion. Participants were classified as non-responders if they did not receive study medication.
Proportion of subjects without residual invasive cancer in the breast and axilla from randomization to definitive surgery. \- Residual invasive cancer defined based on hematoxylin and eosin evaluation of complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by pathologist assessment.
Outcome measures
| Measure |
Arm A: THP
n=58 Participants
Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
|
Arm B: THP-Pembrolizumab
n=58 Participants
Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
Arm C: TH-Pembrolizumab
n=22 Participants
Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
|---|---|---|---|
|
Pathological Complete Response (pCR)
|
28 Participants
|
39 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 16 weeks from randomizationProportion of subjects without residual invasive and in situ cancer in the breast and axilla disease from randomization to definitive surgery. \- Residual invasive cancer and in situ disease defined based on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by pathological assessment.
Outcome measures
| Measure |
Arm A: THP
n=58 Participants
Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
|
Arm B: THP-Pembrolizumab
n=58 Participants
Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
Arm C: TH-Pembrolizumab
n=22 Participants
Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
|---|---|---|---|
|
Pathological Complete Invasive and in Situ Response Rate (Breast and Axilla)
|
25 Participants
|
30 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 16 weeks from randomizationPopulation: Data shown are for the intention-to-treat population, which is defined as any subject who was randomized regardless of treatment completion. Participants were classified as non-responders if they did not receive study medication or had missing data regarding pathological complete response for any reason.
Proportion of subjects without residual invasive cancer in the breast from randomization to definitive surgery. \- Residual invasive breast cancer defined based on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant systemic therapy by pathological assessment.
Outcome measures
| Measure |
Arm A: THP
n=58 Participants
Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
|
Arm B: THP-Pembrolizumab
n=58 Participants
Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
Arm C: TH-Pembrolizumab
n=22 Participants
Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
|---|---|---|---|
|
Pathological Complete Response Rate (pCR) in Breast Only
|
28 Participants
|
39 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 16 weeks from randomizationPopulation: RCB was evaluated among the modified intention-to-treat population, defined as patients who received at least one dose of study treatment.
Proportion of subjects with RCB 0-I, II or III from randomization to definitive surgery. -Residual Cancer Burden defined based on the RCB index, a component of four pathological parameters: bi-dimensional diameter of primary tumor bed, percent of cellularity in the tumor bed, number of involved lymph nodes and size of the largest nodal metastasis. The RCB possible scores are: * RCB-0: Represents a pathologic complete response (pCR), meaning no residual invasive breast cancer was found after neoadjuvant therapy. * RCB-I: Indicates a minimal residual disease burden. * RCB-II: Represents a moderate residual disease burden. * RCB-III: Indicates an extensive residual disease burden. Therefore, higher score indicates worse outcome.
Outcome measures
| Measure |
Arm A: THP
n=58 Participants
Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
|
Arm B: THP-Pembrolizumab
n=58 Participants
Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
Arm C: TH-Pembrolizumab
n=20 Participants
Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
|---|---|---|---|
|
Residual Cancer Burden (RCB)
RBC-0-1
|
39 Participants
|
44 Participants
|
13 Participants
|
|
Residual Cancer Burden (RCB)
RBC-2
|
14 Participants
|
12 Participants
|
6 Participants
|
|
Residual Cancer Burden (RCB)
RBC-3
|
5 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 16 weeks from randomizationProportion of subjects who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer from randomization to definitive surgery (breast conserving surgery).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 months from randomizationMean difference in time (in months) from randomization to any of the following events progression of disease that precludes surgery, local or distant recurrence, or death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 33 months from surgeryMean difference in time (in months) from date of surgery (date of no disease) to the first documentation of invasive progressive disease or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 months from randomizationMean difference in time (in months) from randomization to death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 36 months from randomizationPopulation: This outcome measure was inadvertently added at the time of registration but since it is not a pre-specified outcome within the protocol, no data was collected for this outcome and hence no data to report here.
This outcome measure was inadvertently included in the original registration of the record (by a different organization- this is a transfer record). This specific outcome was never a pre-specified outcome within any version of the protocol. The error was not caught until we began to enter and report results. No data was ever collected for this outcome and hence no data can be reported. There is no plan to collect or analyze data in the future as the outcome was added in error and should have been removed prior to reporting results.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 20 weeks from treatment initiationIncidence and severity of adverse events (AE) and serious adverse events (SAE) from cycle 1 day 1 until 30 days post-surgery. -AEs and SAEs based on CTCAE 5.0
Outcome measures
Outcome data not reported
Adverse Events
Arm A: THP
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
Arm B: THP-Pembrolizumab
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Arm C: TH-Pembrolizumab
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A: THP
n=58 participants at risk
Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
|
Arm B: THP-Pembrolizumab
n=58 participants at risk
Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
Arm C: TH-Pembrolizumab
n=20 participants at risk
Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
1.7%
1/58 • Number of events 2 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
1.7%
1/58 • Number of events 2 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
0.00%
0/20 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/58 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
1.7%
1/58 • Number of events 1 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
0.00%
0/20 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
0.00%
0/58 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
1.7%
1/58 • Number of events 1 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
5.0%
1/20 • Number of events 1 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Cardiac disorders
congestive heart failure
|
1.7%
1/58 • Number of events 1 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
0.00%
0/58 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
0.00%
0/20 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
Other adverse events
| Measure |
Arm A: THP
n=58 participants at risk
Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
|
Arm B: THP-Pembrolizumab
n=58 participants at risk
Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pertuzumab: Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
Arm C: TH-Pembrolizumab
n=20 participants at risk
Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab
All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
Paclitaxel: All subjects will receive Paclitaxel weekly for 12 weeks
Trastuzumab: All subjects will receive Trastuzumab every 3 weeks
Pembrolizumab: Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
22.4%
13/58 • Number of events 14 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
22.4%
13/58 • Number of events 16 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
15.0%
3/20 • Number of events 3 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
25.9%
15/58 • Number of events 23 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
17.2%
10/58 • Number of events 23 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
10.0%
2/20 • Number of events 2 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
41.4%
24/58 • Number of events 34 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
44.8%
26/58 • Number of events 38 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
15.0%
3/20 • Number of events 3 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Hepatobiliary disorders
Elevated ALT
|
17.2%
10/58 • Number of events 18 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
12.1%
7/58 • Number of events 13 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
15.0%
3/20 • Number of events 3 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.0%
11/58 • Number of events 12 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
22.4%
13/58 • Number of events 14 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
15.0%
3/20 • Number of events 3 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
General disorders
Fatigue
|
36.2%
21/58 • Number of events 25 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
32.8%
19/58 • Number of events 22 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
15.0%
3/20 • Number of events 4 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
17.2%
10/58 • Number of events 13 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
12.1%
7/58 • Number of events 7 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
10.0%
2/20 • Number of events 2 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
19.0%
11/58 • Number of events 12 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
8.6%
5/58 • Number of events 6 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
5.0%
1/20 • Number of events 1 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
31.0%
18/58 • Number of events 22 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
25.9%
15/58 • Number of events 21 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
20.0%
4/20 • Number of events 4 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Nervous system disorders
Peripheral Neuropathy
|
25.9%
15/58 • Number of events 18 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
22.4%
13/58 • Number of events 20 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
25.0%
5/20 • Number of events 12 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.7%
12/58 • Number of events 18 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
32.8%
19/58 • Number of events 48 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
20.0%
4/20 • Number of events 4 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
8.6%
5/58 • Number of events 7 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
10.3%
6/58 • Number of events 9 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
20.0%
4/20 • Number of events 6 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomitting
|
8.6%
5/58 • Number of events 8 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
6.9%
4/58 • Number of events 6 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
15.0%
3/20 • Number of events 7 • Averse event data were collected during the neoadjuvant phase, which spans from the initiation of treatment to the day of surgery, 16 weeks.
22 patients were randomized to Arm C; however, two patients withdrew consent before study treatment was initiated. SAE/AE analysis was conducted in the safety population which is defined as patients who had a least one dose of study treatment.
|
Additional Information
Dr. Heather McArthur, Professor IM-Hem Onc
University of Texas Southwestern Medical Center
Phone: 214-645-9380
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place