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

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Epirubicine; Drug: Cyclophosphamide; Drug: Aromatase Inhibitor; Drug: Docetaxel; Drug: Paclitaxel; Drug: 5-Fluorouracil (5FU); Drug: Bevacizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00773695

ML21744

Details and patient eligibility

About

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).

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (</=) 2
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 4 patient groups

Chemotherapy

Active Comparator group

Description:

Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks.

Treatment:

Drug: Epirubicine

Drug: Paclitaxel

Drug: 5-Fluorouracil (5FU)

Drug: Docetaxel

Drug: Cyclophosphamide

Chemotherapy and Bevacizumab

Experimental group

Description:

Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks. Participants will also receive concurrent treatment with bevacizumab every 3 weeks for 24 weeks.

Treatment:

Drug: Bevacizumab

Drug: Epirubicine

Drug: Paclitaxel

Drug: 5-Fluorouracil (5FU)

Drug: Docetaxel

Drug: Cyclophosphamide

Endocrine Therapy

Active Comparator group

Description:

Participants will receive aromatase inhibitor therapy at discretion of the investigator for a period of 24 weeks.

Treatment:

Drug: Aromatase Inhibitor

Endocrine Therapy and Bevacizumab

Experimental group

Description:

Participants will receive aromatase inhibitor therapy at discretion of the investigator and concurrent treatment with bevacizumab for a period of 24 weeks.

Treatment:

Drug: Bevacizumab

Drug: Aromatase Inhibitor