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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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This study aims to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.
The study evaluate the pathological complete response rate, event-free survival, disease-free survival, overall survival and safety of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer. Patients will receive 4 cycles of pyrotinib in combination with trastuzumab, pertuzumab and nab-paclitaxel or 4 cycles of trastuzumab, pertuzumab and nab-paclitaxel as neoadjuvant therapy, then undergo surgery, then receive adjuvant chemotherapy and targeted therapy according to pathologic response and physician's choice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pyrotinib, trastuzumab, pertuzmab and paclitaxel | Experimental | Prior to surgery: pyrotinib, trastuzumab, pertuzumab and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery：
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| Trastuzumab, pertuzmab and paclitaxel | Active Comparator | Prior to surgery: trastuzumab, pertuzumab and nab-paclitaxel for 4 cycles (1 cycle = 21 days). After surgery：
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pyrotinib | Drug | Pyrotinib 400 mg taken orally everyday, every 3 weeks, for 4 cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Total Pathologic Complete Response (tpCR) | tpCR is defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes after completion of neoadjuvant therapy and surgery (that is, ypT0/is, ypN0, in accordance with the current American Joint Committee on Cancer [AJCC] staging system).The duration of one treatment cycle is 21 days. | After completion of 4 cycles of neoadjuvant therapy. The duration of one treatment cycle is 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Breast Pathologic Complete Response (bpCR) | bpCR is defined as the absence of any residual invasive cancer on the hematoxylin and eosin evaluation of the resected breast specimen after completion of neoadjuvant therapy and surgery (that is, ypT0/is, in accordance with current AJCC staging system).The duration of one treatment cycle is 21 days. | After completion of 4 cycles of neoadjuvant therapy The duration of one treatment cycle is 21 days. at the time of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With At Least One Adverse Event During Treatment Period | The percentage of participants who experienced at least one adverse event during the neoadjuvant period, surgery, adjuvant treatment period. | From randomization to 30 days after completion of study treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kunwei Shen, MD,PhD | Ruijin Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
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| Trastuzumab | Drug | Trastuzumab IV infusion in 3-week cycles. Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4. Adjuvant treatment: 8 mg/kg loading dose, followed by 6 mg/kg for remaining cycles till completion of 1 year trastuzumab |
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| Pertuzumab | Drug | Pertuzumab IV infusion in 3-week cycles. Neoadjuvant treatment: 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4. Adjuvant treatment: 840 mg loading dose, followed by 420mg for remaining cycles till completion of 1 year pertuzumab |
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| Nab-paclitaxel | Drug | Nab-paclitaxel 100mg/m2 by intravenous (IV) infusion on day1, day8 and day15, every 3 weeks, for 4 cycles. |
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| EC chemotherapy | Drug | Epirubicin 90 mg/m2, and cyclophosphamide 600 mg/m2 by intravenous (IV) infusion every 3 weeks for 4 cycles (Cycles 5-8) |
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| Physician's choice | Drug | Physician decided chemotherapy for 0-4 cycles. |
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| T-DM1 | Drug | T-DM1 IV infusion in 3-week cycles. 3.6 mg/kg by intravenous (IV) infusion every 3 weeks for 14 cycles |
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| Surgery | Procedure | All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated. |
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| Clinical response | Percentage of Participants With Complete Response, Partial Response, Stable Disease, or Progressive Disease During Cycles 1-4, According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. The duration of one treatment cycle is 21 days. | Cycle 1-4. The duration of one treatment cycle is 21 days. |
| Event-free survival (EFS) | EFS is defined as the time from randomization to the first documentation of one of the following events: Disease progression (before surgery) as determined by the investigator with use of RECIST v1.1 Any evidence of contralateral disease in situ was not identified as progressive disease; Disease recurrence (local, regional, distant, or contralateral) after surgery; Death from any cause. | From Baseline to EFS event or date last known to be alive and event-free (up to 5 years) |
| Disease-free survival (DFS) | DFS was defined as the time from first date of no disease (i.e., date of surgery) to first documentation of one of the following events: Disease recurrence (local, regional, distant, or contralateral) after surgery. Any evidence of contralateral disease in situ was not identified as disease recurrence; Death from any cause. | From surgery to DFS event or date last known to be alive and event-free (up to 5 years) |
| Overall survival (OS) | OS was defined as the time from randomization to death from any cause. | From Baseline to OS event or date last known to be alive (up to 5 years) |
| ID | Term |
|---|---|
| C000622954 | pyrotinib |
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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