Efficacy and Safety of Bevacizumab in the Neodjuvant Treatment of Inflammatory Breast Cancer

Sponsor
Association Tunisienne de lutte Contre le Cancer
Study ID
NCT01880385
Phase
PHASE1
Status
Unknown

Conditions

  • Inflammatory Breast Cancer

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    During neoadjuvant phase: 15 mg/kg, d1 q3w, 4 cycles
  • Cyclophosphamide — DRUG
    Neoadjuvant: 500 mg/m2 d1 q3w, 4 cycles
  • epirubicin hydrochloride — DRUG
    Neoadjuvant: 100 mg/m2, d1 q3w, 4 cycles
  • fluorouracil — DRUG
    Neoadjuvant: 500 mg/m2, d1 q3w, 4 cycles
  • Docetaxel — DRUG
    Adjuvant: 100 mg/m2 q3w, 4 cycles
  • Trastuzumab — BIOLOGICAL
    Adjuvant: 8 mg/kg d1 in the 1st cycle then 6 mg/kg for d1 q3w, 17 cycles if tumor overexpress HER2

Study Details

Multi-center, non randomised, open label, non controlled pilot study. Evaluating the treatment of bevacizumab in association with pre-operative chemotherapy, followed by surgery, adjuvant chemotherapy and radiotherapy in Patients with inflammatory breast cancer.

Key Dates

First listed
Jun 19, 2013
Start date
Mar 31, 2011
Status verified
Jun 2013
Primary completion
Sep 30, 2013
Completion
Apr 30, 2017

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: bevacizumab, inflammatory breast cancer
    Neoadjuvant therapy associating bevacizumab, cyclophosphamide, fluorouracil and epirubicin hydrochloride q3w, 4 cycles Adjuvant therapy by docetaxel q3w, 4 cycles +/- trastuzumab q3w, 18 cycles if tumors overexpress HER2

Primary Outcome Measure

pathologic Complete Response (pCR) [ Time Frame: 18 months ]

Central Contacts

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