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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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00773695
First Posted: October 16, 2008
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Norwegian Radium Hospital
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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).

Condition Intervention Phase
Breast Cancer Drug: Aromatase Inhibitor Drug: Bevacizumab Drug: Epirubicine Drug: 5-Fluorouracil (5FU) Drug: Cyclophosphamide Drug: Paclitaxel Drug: Docetaxel Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Phase II Clinical Trial to Evaluate the Effect of Avastin in Combination With Neoadjuvant Treatment Regimens on the Molecular and Metabolic Characteristics and Changes in the Primary Tumors With Reference to the Obtained Responses in Patients With Large Primary HER2 Negative Breast Cancers

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 [ Time Frame: 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 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) ]

Enrollment: 150
Actual Study Start Date: November 7, 2008
Estimated Study Completion Date: January 16, 2023
Estimated Primary Completion Date: January 16, 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chemotherapy
Participants will receive epirubicine, 5-fluorouracil, and cyclophosphamide (FEC 100) for 12 weeks followed by taxane therapy (paclitaxel or docetaxel) for next 12 weeks.
Drug: Epirubicine
Participants will receive epirubicine at a dose of 100 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
Drug: 5-Fluorouracil (5FU)
Participants will receive 5FU at a dose of 600 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
Drug: Cyclophosphamide
Participants will receive cyclophosphamide at a dose of 600 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
Drug: Paclitaxel
Participants will receive paclitaxel at a dose of 80 mg/m^2 as IV infusion every week for 12 weeks.
Drug: Docetaxel
Participants will receive docetaxel at a dose of 100 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
Experimental: Chemotherapy and 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.
Drug: Bevacizumab
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.
Other Name: Avastin
Drug: Epirubicine
Participants will receive epirubicine at a dose of 100 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
Drug: 5-Fluorouracil (5FU)
Participants will receive 5FU at a dose of 600 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
Drug: Cyclophosphamide
Participants will receive cyclophosphamide at a dose of 600 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
Drug: Paclitaxel
Participants will receive paclitaxel at a dose of 80 mg/m^2 as IV infusion every week for 12 weeks.
Drug: Docetaxel
Participants will receive docetaxel at a dose of 100 mg/m^2 as IV infusion every 3 weeks for 12 weeks.
Active Comparator: Endocrine Therapy
Participants will receive aromatase inhibitor therapy at discretion of the investigator for a period of 24 weeks.
Drug: Aromatase Inhibitor
Participants will receive aromatase inhibitor therapy, at a dose per investigator discretion, once daily for 24 weeks.
Experimental: Endocrine Therapy and Bevacizumab
Participants will receive aromatase inhibitor therapy at discretion of the investigator and concurrent treatment with bevacizumab for a period of 24 weeks.
Drug: Aromatase Inhibitor
Participants will receive aromatase inhibitor therapy, at a dose per investigator discretion, once daily for 24 weeks.
Drug: Bevacizumab
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.
Other Name: Avastin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773695


Locations
Norway
The Norvegian Radium Hospital Montebello; Dept of Oncology
Oslo, Norway, 0379
Ullevael Sykehus; Dept of Oncology
Oslo, Norway, 0407
St. Olavs Hospital; Kreftavdelingen
Trondheim, Norway, 7000
Sponsors and Collaborators
Hoffmann-La Roche
Norwegian Radium Hospital
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00773695     History of Changes
Other Study ID Numbers: ML21744
First Submitted: October 15, 2008
First Posted: October 16, 2008
Last Update Posted: August 28, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Bevacizumab
Cyclophosphamide
Fluorouracil
Epirubicin
Aromatase Inhibitors
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists