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

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy & Safety of Bevacizumab as Neoadjuvant Treatment in Patients With Locally Advanced Inflammatory Breast Cancer, a Pilot Study.

Brief Summary: 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.

Detailed Summary:

Pilot study evaluating the safety and efficacy of adding Bevacizumab to neoadjuvant chemotherapy in patients presenting non metastatic inflammatory breast cancer (IBC). Patients will receive 4 cycles of chemotherapy FEC100 associating Fluorouracil (500 mg/m2), Epirubicin (100 mg/m2), Cyclophosphamide (500 mg/m2) and Bevacizumab 15 mg/kg every at day 1 of ecah 21 days cycle for 4 cycles. Six weeks after the end of neoadjuvant chemotherapy, patients will undergo mastectomy and 4 cycles of Docetaxel (100 mg/m2)as adjuvant chemotherapy +/-Trastuzumab 8 mg/kg for the first cycle then 6mg/kg every 3 weeks for 17 cycles if tumor overexpress Human Epidermal Growth Factor Receptor 2 (HER2).

The primary objective of this study is to evaluate the safety and the efficacy, i.e. pathologic complete response (pCR) after 4 cycles of FEC100+Bevacizumab in IBC


Sponsor: Association Tunisienne de lutte Contre le Cancer

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

Evaluation of the pathologic complete response (pCR) rate among patients treated by 4 cycles of FEC100 and bevacizumab


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Toxicity as assessed by CTCAE v3.0 [ Time Frame: 3 and 5 years ]
    Evaluation of the safety of administering bevacizumab in the neoadjuvant setting, with particular attention on the incidence of grade 3/4 adverse events
  • Progression-free survival [ Time Frame: 3 and 5 years ]
  • Overall survival [ Time Frame: 3 and 5 years ]


Original Secondary Outcome: Same as current

Information By: Association Tunisienne de lutte Contre le Cancer

Dates:
Date Received: May 25, 2011
Date Started: March 2011
Date Completion: April 2017
Last Updated: June 14, 2013
Last Verified: June 2013