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This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pyrotinib-initiated arm | Experimental | two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab |
|
| Pertuzumab-initiated arm | Active Comparator | four cycles of docetaxel + trastuzumab + pertuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pyrotinib | Drug | pyrotinib 320mg p.o. qd |
| |
| pertuzumab |
| Measure | Description | Time Frame |
|---|---|---|
| ctDNA clearance after one cycle neoadjuvant treatment | The rate of ctDNA clearance after first cycle of neoadjuvant treatment | 3 months after neoadjuvant treatment initation |
| Measure | Description | Time Frame |
|---|---|---|
| ctDNA clearance after two cycle neoadjuvant treatment | The rate of ctDNA clearance after first two cycles of neoadjuvant treatments | 3 months after neoadjuvant treatment initation |
| pCR rate | After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained mamtectomy samples and all ipsilateral lymph node samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haoyu Wang | Contact | 86 18817865256 | meredithwhy@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | 200025 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000622954 | pyrotinib |
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance |
|
| trastuzumab | Drug | trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance |
|
| docetaxel | Drug | docetaxel ivgtt q3w, 80-100mg/m2 |
|
| 6 months after neoadjuvant treatment initation |
| bpCR rate | After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained breast samples | 6 months after neoadjuvant treatment initation |
| ORR | The proportion of patients whose tumor volume shrinks to a prespecified value and is able to maintain the minimum time limit, defined as the sum of the proportion of complete response (CR) and partial response (PR, with a reduction in tumor length and diameter greater than 30%). | 6 months after neoadjuvant treatment initation |
| EFS | The time interval from randomization to the first recording of the following events: disease progression (before surgery), as determined by investigator reference RECIST1.1, combined with clinical evaluation, final judgment; postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause | 2 years after surgery |
| DFS | The time interval from the first date of disease-free (i.e., the date of surgery) to the first recording of the following events; Postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause. | 2 years after surgery |
| OS | Time interval from randomization to death from any cause. | 5 years after surgery |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |