Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients

Sponsor
UNICANCER
Study ID
NCT00820547
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    During neoadjuvant phase: 15 mg/kg, d1 q3w, 8 cycles During adjuvant phase:15 mg/kg, d1 q3w, 10 cycles
  • cyclophosphamide — DRUG
    Neoadjuvant: 500 mg/m2 d1 q3w, 4 cycles
  • docetaxel — DRUG
    Neoadjuvant: 100 mg/m2 q3w, 4 cycles
  • epirubicin hydrochloride — DRUG
    Neoadjuvant: 100 mg/m2, d1 q3w, 4 cycles
  • fluorouracil — DRUG
    Neoadjuvant: 500 mg/m2, d1 q3w, 4 cycles

Study Details

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer.

Key Dates

First listed
Jan 12, 2009
Start date
Jan 31, 2009
Status verified
Oct 2019
Primary completion
Apr 30, 2015
Completion
Sep 30, 2019

Study Design

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

Arms

  • Experimental: (FEC / Docetaxel) + Bevacizumab
    Neoadjuvant treatment: 4 cycles FEC + Bevacizumab followed by 4 cycles Docetaxel + Bevacizumab Adjuvant: Bevacizumab for 1 year

Primary Outcome Measure

Complete histologic response rate [ Time Frame: Post surgery ]

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