Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Locally Advanced Breast Cancer; Metastatic Breast Cancer

Treatments: Drug: Gemcitabine; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00623233

B9E-US-S379 (Other Identifier)

11649

Details and patient eligibility

About

To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.

Enrollment: 52 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be female and greater than or equal to 18 yrs of age
• Participants must have confirmed cancer with measurable or evaluable, locally recurrent or metastatic disease.
• Participants must have received a taxane as neo-adjuvant and/or adjuvant therapy
• Participants may have received prior hormone therapy for locally recurrent or metastatic disease

Exclusion criteria

• Participants with breast cancer overexpressing Human Epidermal growth factor Receptor 2 (HER2) gene amplification
• Prior chemotherapy or targeted therapy for metastatic breast cancer
• Prior treatment with gemcitabine, trastuzumab, lapatinib or bevacizumab in any setting
• History of, or active brain mets
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to treatment, or anticipation of need for major surgical procedure during course of study
• Prior history of high blood pressure crisis
• Have a serious, nonhealing wound, ulcer, or bone fracture

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Gemcitabine + Bevacizumab

Experimental group

Description:

Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity. Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.

Treatment:

Drug: Bevacizumab

Drug: Gemcitabine