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Triple-negative breast cancer (TNBC) is a special type of breast cancer, endocrine therapy and targeted therapy are completely ineffective, chemotherapy is currently the only effective treatment. How to improve postoperative pathologic complete response(pCR)of neoadjuvant chemotherapy is critical problem to prolong event-free survival (EFS) and overall survival (OS) of TNBC patients. Apatinib is a new oral small molecule tyrosine protease inhibitor, it is effective in inhibiting angiogenesis with a very low concentration. So the standard neoadjuvant chemotherapy regimen of docetaxel and carboplatin combined with apatinib may improve the postoperative pCR and survival outcomes of TNBC patients. Safety and tolerability assessed by number of grade 3 and 4 toxicities and hospitalizations.
All enrolled patients were administered oral apatinib at a dose of 250 mg once daily and intravenously docetaxel (100 mg/m2) every three weeks for four cycles, followed by epirubicin (90 mg/m2) plus cyclophosphamide (600 mg/m2) every three weeks for four cycles. All the treatments were continued until disease progression, patient withdrawal, or unacceptable toxic effects. Granulocyte colony-stimulating factor (G-CSF) used for prophylaxis of febrile neutropenia was permitted according to the American Society of Clinical Oncology (ASCO) guidelines. The biochemical and hematological indexes were evaluated every cycle. Dose modifications of chemotherapy agents, including dose interruptions and dose reductions, were permitted due to certain adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Four cycles of docetaxel combined with apatinib followed by four cycles of epirubicin and cyclophosphamide as Neoadjuvant Treatment for Triple-Negative Breast Cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | All enrolled patients were administered oral apatinib at a dose of 250 mg once daily and intravenously docetaxel (100 mg/m2) every three weeks for four cycles, followed by epirubicin (90 mg/m2) plus cyclophosphamide (600 mg/m2) every three weeks for four cycles. All the treatments were continued until disease progression, patient withdrawal, or unacceptable toxic effects. |
| Measure | Description | Time Frame |
|---|---|---|
| The pathological complete response (pCR) rate in the breast and lymph nodes (ypTis/0ypN0) | Absence of invasive tumor cells in the breast and lymph nodes and was determined by a local pathologist | up to 24 weeks (at the end of cycle 8, each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | ORR was assessed according to RECIST version 1.1, which included patients with measurable disease who achieved a complete or partial response of target lesions. | up to 24 weeks (at the end of cycle 8, each cycle is 21 days) |
| Event-free survival (EFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kun Wang | Guangdong Provincial People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong general hospital | Guangzhou | Guangdong | 510080 | China | ||
| Guangdong General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35983024 | Derived | Yang C, Zhang J, Zhang Y, Ji F, Chen Y, Zhu T, Zhang L, Gao H, Yang M, Li J, Cheng M, Wang K. Low-dose apatinib combined with neoadjuvant chemotherapy in the treatment of early-stage triple-negative breast cancer (LANCET): a single-center, single-arm, phase II trial. Ther Adv Med Oncol. 2022 Aug 12;14:17588359221118053. doi: 10.1177/17588359221118053. eCollection 2022. |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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|
The interval from the start of treatment to progression prior to surgery, post-surgery recurrence, or death due to any cause |
| up to 24 months |
| Overall survival (OS) | The time from registration to death from any cause | up to 24 months |
| Adverse events | The treatment-related adverse events were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE 4.0). | up to 24 weeks |
| Guangzhou |
| China |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |