Low-dose Apatinib Combined With Neoadjuvant Chemotherapy in the Treatment of Early Triple Negative Breast Cancer

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT03243838
Phase
PHASE2
Status
Completed

Conditions

  • Triple-Negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 1, 2018
Status verified
Jan 2022
Primary completion
Oct 13, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group
    Four cycles of docetaxel combined with apatinib followed by four cycles of epirubicin and cyclophosphamide as Neoadjuvant Treatment for Triple-Negative Breast Cancer

Primary Outcome Measure

The pathological complete response (pCR) rate in the breast and lymph nodes (ypTis/0ypN0) [ Time Frame: up to 24 weeks (at the end of cycle 8, each cycle is 21 days) ]

Related Studies