Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer

Sponsor
RenJi Hospital
Study ID
NCT03982485
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Apatinib — DRUG
    Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week
  • Paclitaxel — DRUG
    Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle
  • Cisplatin — DRUG
    Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle
  • Surgery — PROCEDURE
    Surgery

Study Details

RATIONALE: The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients. Apatinib is a highly potent human vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor that has been independently developed in China, and it can exert anti-angiogenic effects by inhibiting VEGFR2. It is unknown whether giving combination neoadjuvant chemotherapy together with apatinib is more effective in treating patients with nonmetastatic HER2-negative breast cancer. PURPOSE: To explore the efficacy and safety of apatinib added to weekly paclitaxel and cisplatin neoadjuvant therapy for HER-2 negative breast cancer patients

Key Dates

Start date
Oct 16, 2018
Status verified
Apr 2024
Primary completion
Mar 29, 2023
Completion
Mar 29, 2031

Study Design

Enrollment
196 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Apatinib+Paclitaxel+Cisplatin
  • Active Comparator: Arm II
    Paclitaxel+Cisplatin

Primary Outcome Measure

Residual cancer burden (RCB 0-I rates） [ Time Frame: Time of surgery ]

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