Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer

Sponsor
Hebei Medical University Fourth Hospital
Study ID
NCT03580395
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    500mg, day1-21,neoadjuvant therapy
  • paclitaxel — DRUG
    paclitaxel 165mg/m2 day 1
  • cisplatin — DRUG
    cisplatin 40mg, day 1-3

Study Details

To verify the role of apatinib in neoadjuvant therapy for breast cancer, the investigators designed a prospective, randomized, parallel-controlled phase II/III trial, to investigate the efficacy and safety of apatinib combined with TP (paclitaxel + cisplatin) or TP regimen alone as neoadjuvant therapy for stage II-III breast cancer treatment. 100 cases of eligible patients were diagnosed by core needle biopsy and immunohistochemistry, with the molecular subtypes of triple-negative, HER2+ or Luminal B, evaluated by pathological complete remission (pCR), objective response rate (ORR), adverse events, disease free survival (DFS) and OS, aiming at providing a new way for neoadjuvant therapy in breast cancer and anti-angiogenic treatment of malignant tumors.

Key Dates

Start date
Jun 1, 2017
Status verified
Jul 2021
Primary completion
Jul 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: apatinib+TP
    TP neoadjuvant chemotherapy (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3) combined with apatinib (received TP concurrently with apatinib 500mg, day1-21).
  • Sham Comparator: TP
    TP neoadjuvant chemotherapy alone (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3).

Primary Outcome Measure

The primary endpoint is pathological complete remission (pCR) [ Time Frame: 4 months ]

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