A Phase 2, Randomized, Open-Label Study Of Bosutinib Administered In Combination With Exemestane Versus Exemestane Alone As Second Line Therapy In Postmenopausal Women With Locally Advanced Or Metastatic ER+/PgR+/ErbB2- Breast Cancer
18 Years
N/A
Female
Advanced Breast Cancer
Trial Information
A Phase 2, Randomized, Open-Label Study Of Bosutinib Administered In Combination With Exemestane Versus Exemestane Alone As Second Line Therapy In Postmenopausal Women With Locally Advanced Or Metastatic ER+/PgR+/ErbB2- Breast Cancer
This study was terminated on 19 Apr 2010 due to unfavorable risk benefit ratio which did not
support continuation in part 2 of the study. Even if the safety profile of the combination
of Bosutinib and Exemestane was acceptable 25% of subjects had treatment related liver
events including 14% of severe liver events.
Inclusion Criteria:
- Woman aged 18 years or older.
- Confirmed pathologic diagnosis of breast cancer.
- Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to
curative treatment with surgery or radiotherapy.
- Surgically sterile or postmenopausal woman.
- Documented ER+ and/or PgR+ and erbB2- tumor.
- Progression of locally advanced or metastatic disease during treatment with a
nonsteroidal AI or tamoxifen, or progression during treatment with (or within 6
months of discontinuation of) an adjuvant nonsteroidal AI.
Exclusion Criteria:
- Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.
- More than 1 prior endocrine treatment for locally advanced or MBC.
- More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.
- Bone or skin as the only site of disease.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival (PFS) Based on Independent Radiologist
Outcome Description:
Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Outcome Time Frame:
Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
3160A6-2206
NCT ID:
NCT00793546
Start Date:
February 2009
Completion Date:
June 2010
Related Keywords:
- Advanced Breast Cancer
- Bosutinib
- Exemestane
- postmenopausal
- breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Federal Way, Washington 98003 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Livingston, New Jersey 07039 |
