Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer
NCT00880009
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer | |||
Official Title ICMJE | 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 | |||
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 receive bosutinib and letrozole daily, and will be closely monitored for 28 days. The second part will proceed with subjects receiving a dose that is determined to be safe based on the safety evaluation of the first part. Eligible subjects will be randomly assigned to receive either bosutinib daily combined with daily letrozole, or daily letrozole alone for a specified period of time. Subjects will be followed up for survival after study drug discontinuation. | |||
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 related liver events with the majority of severe events resulting in permanent study treatment discontinuation. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Moy B, Neven P, Lebrun F, Bellet M, Xu B, Sarosiek T, Chow L, Goss P, Zacharchuk C, Leip E, Turnbull K, Bardy-Bouxin N, Duvillié L, Láng I. Bosutinib in combination with the aromatase inhibitor letrozole: a phase II trial in postmenopausal women evaluating first-line endocrine therapy in locally advanced or metastatic hormone receptor-positive/HER2-negative breast cancer. Oncologist. 2014 Apr;19(4):348-9. doi: 10.1634/theoncologist.2014-0021. Epub 2014 Mar 27. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 16 | |||
Original Estimated Enrollment ICMJE | 250 | |||
Actual Study Completion Date ICMJE | May 2010 | |||
Actual Primary Completion Date | May 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, China, Hong Kong, Hungary, Poland, Singapore, United States | |||
Removed Location Countries | Australia, Brazil, Malaysia | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00880009 | |||
Other Study ID Numbers ICMJE | 3160A6-2207 B1871010 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | October 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |