NCT01880385

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Association Tunisienne de lutte Contre le Cancer · Academic / Other
• Sex: Female
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Inflammatory Breast Cancer

Interventions

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

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-09-01
• Completion: 2017-04-01
• First posted: 2013-06-19
• Last updated: 2013-06-19

Locations

1 site across 1 country: Tunisia