Status:
TERMINATED
Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer
Lead Sponsor:
Pfizer
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a phase 2 study of bosutinib administered in combination with letrozole versus letrozole alone in post-menopausal women with breast cancer. This is a 2-part study. Subjects in part 1 will rece...
Detailed Description
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 relat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00880009
Start Date
July 30 2009
End Date
May 31 2010
Last Update
September 27 2021
Active Locations (11)
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1
American Institute of Research
Whittier, California, United States, 90603
2
Joliet Oncology Hematology Associates
Joliet, Illinois, United States, 60435
3
Oncology Specialists SC
Niles, Illinois, United States, 60714
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114