A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2023-01-16
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effect of bevacizumab in combination with chemotherapy or endocrine therapy, as preoperative treatment, in participants with HER2 negative breast cancer. Participants will be randomized to receive either chemotherapy (FEC100: Epirubicine 100 milligrams per square meter [mg/m^2], 5-fluorouracil 600 mg/m^2, and cyclophosphamide 600 mg/m^2] for 12 weeks followed by taxane (paclitaxel/docetaxel) for 12 weeks or endocrine therapy (an aromatase inhibitor] daily for 24 weeks) with or without bevacizumab (15 milligrams per kilogram [mg/kg] as intravenous [IV] infusion every 3 weeks up 24 weeks).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Norwegian Radium Hospital
• Treatments: Aromatase Inhibitors; Bevacizumab; Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed, HER2-negative, men or pre- or post-menopausal women with primary operable adenocarcinoma of the breast, greater than or equal to (>=) 2.5 centimeters (cm) in size

• Eastern Cooperative Oncology Group (ECOG)/world health organization (WHO) performance status less than or equal to (
• Normal baseline cardiac function (Left Ventricular Ejection Fraction [LVEF])

Exclusion Criteria:

• Stage IV (metastatic) disease

• Previous treatment for localized breast cancer less than (<) 24 months from diagnosis of present breast cancer

• Other previous or current cancer except for basal cell cancer or in situ cervical cancer

• Current or recent use of aspirin (greater than [>] 325 milligrams per day)

• Clinically significant cardiovascular disease