Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00623233
First received: February 13, 2008
Last updated: December 2, 2011
Last verified: December 2011

February 13, 2008
December 2, 2011
March 2008
January 2011   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) Time [ 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). ] [ Designated as safety issue: No ]
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.
Progression Free Survival Time [ Time Frame: One Year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00623233 on ClinicalTrials.gov Archive Site
  • Overall Tumor Response Rate (ORR) [ 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). ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, every cycle (every 14 days) up to 34 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline to death from any cause, 1 year ] [ Designated as safety issue: No ]
    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.
  • Overall Tumor Response Rate [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]
  • Pharmacology Toxicities [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • One Year Survival [ Time Frame: One Year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer
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

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Metastatic Breast Cancer
  • Locally Advanced Breast Cancer
  • Drug: Gemcitabine
    Gemcitabine 2500 mg/m^2 IV over 30 minutes given on Day 1 q 14 days prior to bevacizumab until PD or unacceptable toxicity.
    Other Names:
    • Gemzar
    • LLY188011
  • Drug: Bevacizumab

    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.

Experimental: Gemcitabine + 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.

Interventions:
  • Drug: Gemcitabine
  • Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00623233
11649, B9E-US-S379
No
Eli Lilly and Company
Eli Lilly and Company
Genentech
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP