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
Phase 2
Completed
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00773695
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemotherapy Epirubicine Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks. Chemotherapy 5-Fluorouracil (5FU) Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks. Chemotherapy and Bevacizumab 5-Fluorouracil (5FU) 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. Endocrine Therapy Aromatase Inhibitor Participants will receive aromatase inhibitor therapy at discretion of the investigator for a period of 24 weeks. Endocrine Therapy and Bevacizumab Aromatase Inhibitor Participants will receive aromatase inhibitor therapy at discretion of the investigator and concurrent treatment with bevacizumab for a period of 24 weeks. Chemotherapy and Bevacizumab Cyclophosphamide 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. Chemotherapy Cyclophosphamide Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks. Chemotherapy Paclitaxel Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks. Chemotherapy Docetaxel Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks. Chemotherapy and Bevacizumab Epirubicine 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. Chemotherapy and Bevacizumab Bevacizumab 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. Chemotherapy and Bevacizumab Paclitaxel 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. Chemotherapy and Bevacizumab Docetaxel 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. Endocrine Therapy and Bevacizumab Bevacizumab Participants will receive aromatase inhibitor therapy at discretion of the investigator and concurrent treatment with bevacizumab for a period of 24 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Messenger Ribonucleic Acid (mRNA) Markers of Pathological Complete Response, as Assessed by Magnetic Resonance Imaging (MRI) Baseline up to end of study treatment (approximately 24 weeks)
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Presence of Tumor Cells Close to Resection Margin At Surgery (Between Weeks 24 and 25) Percentage of Participants With Objective Pathological Complete Response, as Assessed by Clinical Assessment Baseline up to end of study treatment (approximately 24 weeks) Percentage of Participants With Tumor Deposit in Other Body Parts At Surgery (Between Weeks 24 and 25) Tumor Free Resection Margin At Surgery (Between Weeks 24 and 25) Pathological Tumor Size as Measure Using MRI Baseline, Weeks 12 and 25 Percentage of Participants With Axillary Lymph Node Dissection Performed At Surgery (Between Weeks 24 and 25) Pathological Tumor Size, as Assessed by Histopathological Examination At Surgery (Between Weeks 24 and 25) Pathological Tumor Size as Measure Using Caliper Cycles 1 to 10 (cycle length=21 days), and Week 25 Pathological Axilla Tumor Size as Measure Using Ultrasound Baseline, Weeks 12 and 25 Percentage of Participants With Type of Surgery At Surgery (Between Weeks 24 and 25) Percentage of participants with different surgery types (for example, Mastectomy, Tumorectomy/Breast conserving therapy (BCT), and Tumorectomy followed by mastectomy) will be reported.
Percentage of Participants With Lymph Node Involvement 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) Weeks 12 and 25 Percentage of Participants With New Lesions Weeks 12 and 25 Percentage of Participants With Molecular Changes in Protein Kinase Expression Baseline up to end of study treatment (approximately 24 weeks) Percentage of Participants With Molecular Changes in Messenger Ribonucleic Acid (mRNA)/microRNA(miRNA) Baseline up to end of study treatment (approximately 24 weeks) Percentage of Participants With Molecular Changes in Protein Expression Baseline up to end of study treatment (approximately 24 weeks) Percentage of Participants With Single Nucleotide Polymorphism (SNP) Profiles Predicting Treatment Response 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 Baseline up to end of study treatment (approximately 24 weeks) Pathological Tumor Size as Measure Using Mamography Baseline, Weeks 12 and 25 Pathological Breast Tumor Size as Measure Using Ultrasound Baseline, Weeks 12 and 25 Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Screening, Cycles 1 to 10 (cycle length=21 days), and Week 25 Percentage of Participants With Treatment-Induced Changes in Tumor Cells as Determined by Number of Circulating Tumor Cells in Peripheral Blood Baseline up to end of study treatment (approximately 24 weeks)
Trial Locations
- Locations (3)
Ullevael Sykehus; Dept of Oncology
🇳🇴Oslo, Norway
The Norvegian Radium Hospital Montebello; Dept of Oncology
🇳🇴Oslo, Norway
St. Olavs Hospital; Kreftavdelingen
🇳🇴Trondheim, Norway