A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer

Hoffmann-La Roche736 enrolled

Overview

This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

Five participants randomized to the docetaxel 100 mg/m\^2 plus placebo group actually received docetaxel 100 mg/m\^2 plus bevacizumab 7.5 mg/kg and are included in the docetaxel 100 mg/m\^2 plus bevacizumab 7.5 mg/kg group for the adverse event results. Sixteen participants randomized to the docetaxel 100 mg/m\^2 plus placebo group actually received docetaxel 100 mg/m\^2 plus bevacizumab 15.0 mg/kg and are included in the docetaxel 100 mg/m\^2 plus bevacizumab 15.0 mg/kg group for the adverse event results.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

736

Conditions

Breast Cancer

Interventions

DocetaxelDRUG

Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.

Placebo to bevacizumabDRUG

Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.

BevacizumabDRUG

Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria: * Female patients ≥ 18 years of age. * Human epidermal growth factor receptor 2 (HER2)-negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy. * No adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Exclusion criteria: * Previous chemotherapy for metastatic or locally recurrent breast cancer. * Radiotherapy for treatment of metastatic disease. * Other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix. * Spinal cord compression or brain metastases. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization. * Inadequate bone marrow, liver, or renal function. * Uncontrolled hypertension.

Locations (114)

Outcomes

Primary Outcomes

Progression-free Survival

Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as ≥ 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).

Time frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)

Secondary Outcomes

Percentage of Participants With a Complete Response or a Partial Response

Responses were evaluated using the Response Evaluation Criteria in Solid Tumors. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.

Time frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)

Duration of Response

Duration of response was defined as the time from the first documented complete response or partial response to disease progression or death. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were evaluated using the Response Evaluation Criteria in Solid Tumors.

Time frame: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)

Time to Treatment Failure

Time to treatment failure was defined as time from randomization to the date of disease progression, death, or withdrawal of treatment due to an adverse event, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first.

Data from ClinicalTrials.gov

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Unnamed facility

Adelaide, New South Wales, Australia

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Camperdown, New South Wales, Australia

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Westmead, New South Wales, Australia

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Auchenflower, Queensland, Australia

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Box Hill, Victoria, Australia

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Fitzroy, Victoria, Australia

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Ringwood East, Victoria, Australia

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Perth, Western Australia, Australia

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Graz, Austria

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Salzburg, Austria

...and 104 more locations