Conditions

Metastatic Breast Cancer Locally Advanced Breast Cancer

Keywords

Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

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 Outcomes (3)

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).
Number of Participants With Adverse Events (AEs); Pharmacology Toxicities
Baseline, every cycle (every 14 days) up to 34 months
1-Year Overall Survival (OS) Rate
Baseline to death from any cause, 1 year

Study Arms (1)

Gemcitabine + Bevacizumab

EXPERIMENTAL

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: GemcitabineDrug: Bevacizumab

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.

Also known as: Gemzar, LLY188011

Gemcitabine + Bevacizumab

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.

Gemcitabine + Bevacizumab

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.