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

Hoffmann-La Roche150 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Breast Cancer

Interventions

Participants will receive aromatase inhibitor therapy, at a dose per investigator discretion, once daily for 24 weeks.

BevacizumabDRUG

Bevacizumab will be administered at a dose of 15 mg/kg as IV infusion every 3 weeks (or 10 mg/kg every other week in participants receiving weekly paclitaxel), for 24 weeks.

EpirubicineDRUG

Participants will receive epirubicine at a dose of 100 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.

5-Fluorouracil (5FU)DRUG

Participants will receive 5FU at a dose of 600 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.

CyclophosphamideDRUG

Participants will receive cyclophosphamide at a dose of 600 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.

PaclitaxelDRUG

Participants will receive paclitaxel at a dose of 80 mg/m\^2 as IV infusion every week for 12 weeks.

DocetaxelDRUG

Participants will receive docetaxel at a dose of 100 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

The Norvegian Radium Hospital Montebello; Dept of Oncology

Oslo, Norway

Ullevael Sykehus; Dept of Oncology

Oslo, Norway

St. Olavs Hospital; Kreftavdelingen

Trondheim, Norway

Outcomes

Primary Outcomes

Percentage of Participants With Messenger Ribonucleic Acid (mRNA) Markers of Pathological Complete Response, as Assessed by Magnetic Resonance Imaging (MRI)

Time frame: Baseline up to end of study treatment (approximately 24 weeks)

Secondary Outcomes

Percentage of Participants With Objective Pathological Complete Response, as Assessed by Clinical Assessment

Time frame: Baseline up to end of study treatment (approximately 24 weeks)

Percentage of Participants With Type of Surgery

Percentage of participants with different surgery types (for example, Mastectomy, Tumorectomy/Breast conserving therapy (BCT), and Tumorectomy followed by mastectomy) will be reported.

Time frame: At Surgery (Between Weeks 24 and 25)

Percentage of Participants With Axillary Lymph Node Dissection Performed

Time frame: At Surgery (Between Weeks 24 and 25)

Pathological Tumor Size, as Assessed by Histopathological Examination

Time frame: At Surgery (Between Weeks 24 and 25)

Percentage of Participants With Presence of Tumor Cells Close to Resection Margin

Time frame: At Surgery (Between Weeks 24 and 25)

Percentage of Participants With Tumor Deposit in Other Body Parts

Time frame: At Surgery (Between Weeks 24 and 25)

Tumor Free Resection Margin

Time frame: At Surgery (Between Weeks 24 and 25)

Pathological Tumor Size as Measure Using Caliper

Time frame: Cycles 1 to 10 (cycle length=21 days), and Week 25

Pathological Tumor Size as Measure Using MRI

Time frame: Baseline, Weeks 12 and 25

Pathological Tumor Size as Measure Using Mamography

Time frame: Baseline, Weeks 12 and 25

Pathological Breast Tumor Size as Measure Using Ultrasound

Time frame: Baseline, Weeks 12 and 25

Pathological Axilla Tumor Size as Measure Using Ultrasound

Time frame: Baseline, Weeks 12 and 25

Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status

Time frame: Screening, Cycles 1 to 10 (cycle length=21 days), and Week 25

Percentage of Participants With Lymph Node Involvement

Time frame: Cycles 1 to 10 (cycle length=21 days), and Week 25

Percentage of Participants With Objective Tumor Response, as Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST)

Time frame: Weeks 12 and 25

Percentage of Participants With New Lesions

Time frame: Weeks 12 and 25

Percentage of Participants With Molecular Changes in Protein Kinase Expression

Time frame: Baseline up to end of study treatment (approximately 24 weeks)

Percentage of Participants With Molecular Changes in Messenger Ribonucleic Acid (mRNA)/microRNA(miRNA)

Time frame: Baseline up to end of study treatment (approximately 24 weeks)

Percentage of Participants With Molecular Changes in Protein Expression

Time frame: Baseline up to end of study treatment (approximately 24 weeks)

Percentage of Participants With Single Nucleotide Polymorphism (SNP) Profiles Predicting Treatment Response

Time frame: Baseline up to end of study treatment (approximately 24 weeks)

Percentage of Participants With Treatment-Induced Changes in Tumor Cells as Determined by Number of Disseminated Tumor Cells in Bone Marrow

Time frame: Baseline up to end of study treatment (approximately 24 weeks)

Percentage of Participants With Treatment-Induced Changes in Tumor Cells as Determined by Number of Circulating Tumor Cells in Peripheral Blood

Time frame: Baseline up to end of study treatment (approximately 24 weeks)

Data from ClinicalTrials.gov

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