Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer

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

Official Title
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A Phase 2 Study of Gemcitabine and Bevacizumab as First-Line Treatment in HER2 Negative, Locally Recurrent or Metastatic Breast Cancer Previously Treated With Taxanes

Conditions
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Metastatic Breast Cancer, Locally Advanced Breast Cancer

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine + Bevacizumab<br>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. | Drug: Gemcitabine<br>* Gemcitabine 2500 mg/m^2 IV over 30 minutes given on Day 1 q 14 days prior to bevacizumab until PD or unacceptable toxicity.<br>* Other names: LLY188011;Drug: Bevacizumab<br>* Bevacizumab 10 mg/kg IV over 90 minutes at Cycle 1; infusion time may have been decreased for subsequent cycles. (For example, if the first infusion was tolerated without an infusion-associated adverse event [AE], the second infusion was delivered over 60 minutes. If the 60-minute infusion was well tolerated, all subsequent infusions were delivered over 30 minutes.) Bevacizumab 10 mg/kg initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) Time | 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. | 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). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Tumor Response Rate (ORR) | 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). | 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). | 
| Number of Participants With Adverse Events (AEs); Pharmacology Toxicities | A listing of serious adverse events (SAEs) and other non-serious AEs is located in the Reported Adverse Event module. | Baseline, every cycle (every 14 days) up to 34 months | 
| 1-Year Overall Survival (OS) Rate | 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. | Baseline to death from any cause, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Neoplasm