A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: gemcitabine; Drug: paclitaxel; Drug: bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00320541

10663

B9E-US-S377 (Other Identifier)

Details and patient eligibility

About

This study will compare the cancer response to both treatments for locally advanced or metastatic breast cancer

Enrollment: 187 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs.
• Must be able to measure the disease by specific medical parameters
• May have received breast cancer treatment in the early stage of the disease
• May be restricted in physically strenuous activity but able to carry out light work.
• Must have adequate organ function as seen in blood test results.

Exclusion

Criteria:

• Cancer that has spread to the brain.
• Unstable heart problems
• Unstable high blood pressure.
• Breast cancer treatment after the disease has considered to spread to other areas or organs.
• Unable to agree with the requirements of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

187 participants in 2 patient groups

paclitaxel plus bevacizumab (PB)

Active Comparator group

Description:

paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days

Treatment:

Drug: bevacizumab

Drug: paclitaxel

paclitaxel plus bevacizumab plus gemcitabine (PB+G)

Experimental group

Description:

paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days

Treatment:

Drug: bevacizumab

Drug: paclitaxel

Drug: gemcitabine