A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-04-30

Brief Summary

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This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an area under curve \[AUC\]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Overall Participants

Participants received a combination therapy of bevacizumab with gemcitabine plus carboplatin.

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

15 mg/kg iv every 3 weeks

Carboplatin

Intervention Type DRUG

to an AUC = 2, on days 1 and 8 of each 3-week cycle

Gemcitabine

Intervention Type DRUG

1000 mg/m2 iv on days 1 and 8 of each 3-week cycle

Interventions

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Bevacizumab

15 mg/kg iv every 3 weeks

Intervention Type DRUG

Carboplatin

to an AUC = 2, on days 1 and 8 of each 3-week cycle

Intervention Type DRUG

Gemcitabine

1000 mg/m2 iv on days 1 and 8 of each 3-week cycle

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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Inclusion Criteria

* Female participants, \>/= 18 years of age
* Metastatic breast cancer
* Estrogen receptor-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative disease
* Treatment-naïve for metastatic breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate hematological, renal and liver function
* Patients should have received Anthracyclines and Taxanes in the adjuvant setting
* Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products

Exclusion Criteria

* Prior first line treatment for metastatic breast cancer
* Central nervous system (CNS) metastasis
* Uncontrolled hypertension (\> 170/95 mmHg)
* Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline
* Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
* Prior therapy with gemcitabine or carboplatin in the metastatic setting. Participants having received gemcitabine or carboplatin as part of adjuvant therapy are eligible, if recurrence was first documented \>6 months after the last exposure to the drug(s)
* Requirement of chronic use of immunosuppressive agents
* HIV, hepatitis B or hepatitis C infection

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No