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Completed

NCT Number: NCT00333775

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Adelaide, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

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

Placebo to bevacizumab

Drug

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

Bevacizumab

Drug

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

Other names: Avastin

Primary outcomes

  1. Progression-free Survival

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

    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).

Secondary outcomes

  1. Percentage of Participants With a Complete Response or a Partial Response

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

    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.

  2. Duration of Response

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

    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.

  3. Time to Treatment Failure

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

    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.

  4. Overall Survival

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

    Overall survival was defined as the time from randomization to death from any cause.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Docetaxel in Comparison With Docetaxel Plus Placebo, as First Line Treatment for Patients With HER2 Negative Metastatic and Locally Recurrent Breast Cancer.

Important dates

Study start
2006
Primary completion
2007
Study completion
2013
First posted
Jun 6, 2006
Registry last updated
Jan 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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