NCT00820547

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

Phase II Study Evaluating the Efficacy and Tolerance of Bevacizumab (Avastin) in HER2- Inflammatory Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * Evaluate the complete histological response rate in patients with inflammatory HER2-negative breast cancer treated with bevacizumab and concurrent chemotherapy followed by bevacizumab and concurrent hormonal therapy after surgery and radiotherapy. Secondary * Evaluate the progression-fee and overall survival of these patients at 3 and 5 years. * Evaluate the tolerance of bevacizumab in these patients. * Assess circulating metastatic disease before, during, and after treatment. * Assess circulating endothelial cells before, during, and after treatment. * Assess predictive factors of response by genomic and proteomic studies on frozen tumor samples and fluid samples (i.e., serum and plasma). OUTLINE: This is a multicenter study. * Neoadjuvant induction therapy: * Courses 1-4: Patients receive bevacizumab IV over 30-90 minutes, fluorouracil IV, epirubicin hydrochloride IV over 10 minutes, and cyclophosphamide IV over 5 minutes on day 1. * Courses 5-8: Patients receive bevacizumab IV over 30-90 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. * Surgery: Patients undergo surgery 4-6 weeks after completion of bevacizumab. * Adjuvant therapy: Beginning 2-4 weeks after surgery, patients undergo radiotherapy for 6 weeks. Patients also receive bevacizumab IV over 30-90 minutes beginning 2-4 weeks after surgery, during the radiotherapy period. Treatment with bevacizumab repeats every 3 weeks for 30 weeks in the absence of disease progression or unacceptable toxicity. Patients who are estrogen receptor- or progesterone receptor-positive (≥ 10% by IHC) receive the following concurrent hormonal therapy beginning in week 7: * Premenopausal patients: Patients receive tamoxifen citrate for 5 years. * Postmenopausal patients: Patients receive aromatase-inhibitor therapy (or tamoxifen citrate if unable to tolerate anti-aromatase therapy) for 5 years. * Perimenopausal patients: Patients receive tamoxifen citrate for 2-3 years and aromatase-inhibitor therapy for 2-3 years OR tamoxifen citrate for 5 years followed by aromatase-inhibitor therapy for 2-3 years (if follicle-stimulating hormone \> 30 IU/L and/or estradiol \< 30 ng/L). After completion of study treatment, patients are followed for at least 3 years.

Conditions

• Breast Cancer

Interventions

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

Timeline

• Start date: 2009-01-01
• Primary completion: 2015-04-01
• Completion: 2019-09-01
• First posted: 2009-01-12
• Last updated: 2019-10-22

Locations

28 sites across 1 country: France