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OpenTrials
Completed

NCT Number: NCT00846027

A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer

This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.

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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 2

Primary location

Elda, Alicante, Spain

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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.
  • Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.
  • HER-2 negative disease.
  • Candidates for chemotherapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion criteria

  • Previous chemotherapy for metastatic or locally advanced breast cancer.
  • Previous radiotherapy for treatment of metastatic breast cancer.
  • Any prior adjuvant treatment with anthracyclines completed < 6 months prior to enrollment.
  • Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (> 325 mg/day) or clopidogrel (> 75mg/day).

Treatment and study plan

Bevacizumab

Drug

Bevacizumab was supplied as a sterile liquid in glass vials.

Other names: Avastin

paclitaxel

Drug

Paclitaxel was supplied as a sterile liquid in glass vials.

Other names: Taxol

Gemcitabine

Drug

Gemcitabine was supplied as a sterile liquid in glass vials.

Other names: Gemzar

Primary outcomes

  1. Progression-free Survival

    Time frame: Baseline to the end of the study (up to 2 years 10 months)

    Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.

Secondary outcomes

  1. Percentage of Participants With an Objective Response

    Time frame: Baseline to the end of the study (up to 2 years 10 months)

    An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.

  2. Duration of the Objective Response

    Time frame: Baseline to the end of the study (up to 2 years 10 months)

    Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.

  3. Overall Survival

    Time frame: Baseline to the end of the study (up to 2 years 10 months)

    Overall survival is defined as the time from the first dose of study medication until death.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open Label Study to Assess the Effect of First Line Treatment With Avastin in Combination With Paclitaxel and Gemcitabine in Progression-free Survival in Patients With HER-2 Negative Breast Cancer

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Feb 18, 2009
Registry last updated
Jul 23, 2014

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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