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Brief Title: Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer
Official Title: Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer (LANCET): A Multicenter, Single-arm, Phase II Trial
Study ID: NCT03243838
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Guangdong general hospital, Guangzhou, Guangdong, China
Guangdong General Hospital, Guangzhou, , China
Name: Kun Wang
Affiliation: Guangdong Provincial People's Hospital
Role: STUDY_DIRECTOR