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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

NCT00773695

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: Aromatase Inhibitor, Bevacizumab, Epirubicine, 5-Fluorouracil (5FU), Cyclophosphamide

Countries: Norway

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 (\</=) 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

Locations (3)

Oslo, Norway
Oslo, Norway
Trondheim, Norway