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

Roche

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Carboplatin; Drug: Gemcitabine; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01201265

ML25420

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Overall Participants

Experimental group

Description:

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

Treatment:

Drug: Bevacizumab

Drug: Gemcitabine

Drug: Carboplatin