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To evaluate the efficacy and safety of nab-paclitaxel combined with carboplatin for Chinese patients with triple-negative and HER2-positive breast cancer in the neoadjuvant setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nab-paclitaxel + Carboplatin ± Herceptin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-paclitaxel | Drug | 125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response (ypT0/is ypN0) rate | Absence of invasive cancer in the breast and axillary nodes, irrespective of ductal carcinoma in situ. | 16 weeks (at the time of definitive surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Invasive disease-free survival (IDFS) | IDFS is defined as the time period between registration and first event (ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, second primary nonbreast invasive cancer) | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayi Wu, Dr. | Contact | 0086-21-64370045 | 602268 | pinkscorpio@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Zhu, Prof. | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | 200025 | China |
There is no plan to share IPD
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D016190 | Carboplatin |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
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| Carboplatin | Drug | AUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles |
|
| Herceptin | Drug | In case of HER2-positive, patients receive Herceptin weekly during all cycles. |
|
| Distant disease-free survival (DDFS) | DDFS is defined as the time period between registration and first event (distant recurrence, death attributable to any cause, second primary nonbreast invasive cancer) | 5 years |
| Objective response rate (ORR) | ORR includes all patients whose cancer has a partial or complete response according to RECIST 1.1 | 16 weeks (at the time of definitive surgery) |
| Breast conservation rate | To determine the breast conservation rate after neoadjuvant treatment. | 16 weeks (at the time of definitive surgery) |
| Tolerability and safety: number of patients whose treatment had to be reduced, delayed or permanently stopped | Descriptive statistics will be given on the number of patients whose treatment had to be reduced, delayed or permanently stopped. | during treatment (16 weeks) |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |