A Phase 2, Randomized, Open-Label Study Of Bosutinib Administered In Combination With Letrozole Versus Letrozole Alone As First Line Therapy In Post-Menopausal Women With Locally Advanced Or Metastatic ER+/PgR+/ErbB2- Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
A Phase 2, Randomized, Open-Label Study Of Bosutinib Administered In Combination With Letrozole Versus Letrozole Alone As First Line Therapy In Post-Menopausal Women With Locally Advanced Or Metastatic ER+/PgR+/ErbB2- Breast Cancer
This study was terminated on 19 April 2009 due to unfavorable risk benefit ratio of
Bosutinib in combination with Letrozole including one confirmed Hy's law case. 37.5% of
patients had treatment related liver events with the majority of severe events resulting in
permanent study treatment discontinuation.
Inclusion Criteria:
- Surgically sterile or post-menopausal women.
- Confirmed pathologic diagnosis of breast cancer.
- Locally advanced or metastatic, or loco-regional recurrent breast cancer not amenable
to curative treatment with surgery or radiotherapy.
- Documented ER+ and/or PgR+ and erbB2- tumor based on most recently analyzed biopsy,
as documented by a local laboratory.
- At least 1 radiologically measurable lesion as defined by Response Evaluation
Criteria in Solid Tumors (RECIST).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Exclusion Criteria:
- Prior letrozole (except in adjuvant setting), prior bosutinib, or any other prior Src
inhibitor.
- Prior endocrine treatment for locally advanced or metastatic breast cancer (up to one
prior adjuvant Aromatase Inhibitor (AI) agent/regimen is permitted).
- More than 1 prior chemotherapy regimen in locally advanced or metastatic breast
cancer.
- Adjuvant endocrine therapy <=12 months prior to day 1 of treatment.
- Disease refractory (ie, Progressive disease (PD) within 6 months from initiation of
therapy) to previous adjuvant antiestrogen therapy.
- Bone or skin as the only site of disease.
- Extensive visceral disease or active Central Nervous System (CNS) disease.
- Any other cancer within 5 years of screening with the exception of ER+ contralateral
breast carcinoma, adequately treated cervical carcinoma in situ, or adequately
treated basal or squamous cell carcinoma of the skin.
- Major surgery or radiotherapy within 14 days of treatment day.
- Inadequate hepatic/renal/bone marrow function.
- History of clinically significant or uncontrolled cardiac disease.
- Serious concurrent illness.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: 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 date of randomization to first documentation of objective tumor progression or death due to any cause. PFS: calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression: 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"). PFS assessed by independent radiologist was to be reported.
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:
3160A6-2207
NCT ID:
NCT00880009
Start Date:
July 2009
Completion Date:
May 2010
Related Keywords:
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | North Adams, Massachusetts 01247 |
