Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Metastatic Breast Cancer; Locally Advanced Breast Cancer
• Interventions: Drug: Gemcitabine; Drug: Bevacizumab

• Registration Number: NCT00623233
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-25
• Study Start: 2008-03
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-12
• Results First Submitted: 2011-12-02
• Results First Submitted QC: 2011-12-02
• Last Update Submitted: 2011-12-02
• Results First Posted: 2012-01-09
• Last Update Posted: 2012-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine + Bevacizumab	Gemcitabine	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.
Gemcitabine + Bevacizumab	Bevacizumab	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.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) Time	Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months).	PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date.

Secondary Outcome Measures

Name	Time	Method
Overall Tumor Response Rate (ORR)	Baseline to measured PD. Tumor assessments were performed every 8 weeks (q 8 weeks) during therapy and q 2 months during post-therapy until documented PD (up to 34 months).	Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: complete response (CR)=disappearance of all target lesions; partial response (PR)=30% decrease in sum of longest diameter of target lesions; progressive disease (PD)=20% increase in sum of longest diameter of target lesions; stable disease=small changes that do not meet above criteria. ORR=proportion of participants who achieved a confirmed best response of CR or PR (responders). ORR=number of participants with CR or PR /number of participants qualified for tumor response analysis (per protocol population).
Number of Participants With Adverse Events (AEs); Pharmacology Toxicities	Baseline, every cycle (every 14 days) up to 34 months	A listing of serious adverse events (SAEs) and other non-serious AEs is located in the Reported Adverse Event module.
1-Year Overall Survival (OS) Rate	Baseline to death from any cause, 1 year	OS was measured from the date of first dose to the date of death from any cause. For each participant who was not known to have died as of the data inclusion cut-off date for a particular analysis, OS duration was censored for that analysis at the date of participant's last study contact prior to that cut-off date. The 1-year survival rate (percentage of participants who were alive at 1 year) was estimated from OS data.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇺🇸 Newport News, Virginia, United States