Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer

Eli Lilly and Company52 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Breast Cancer Locally Advanced Breast Cancer

Interventions

GemcitabineDRUG

Gemcitabine 2500 mg/m\^2 IV over 30 minutes given on Day 1 q 14 days prior to bevacizumab until PD or unacceptable toxicity.

BevacizumabDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (16)

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

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).

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Fayetteville, Arkansas, United States

Fresno, California, United States

San Diego, California, United States

Longmont, Colorado, United States

Fairfield, Connecticut, United States

Augusta, Georgia, United States

Lambertville, Michigan, United States

St Louis, Missouri, United States

Great Falls, Montana, United States

New York, New York, United States

...and 6 more locations