Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer
NCT ID: NCT00880009
Last Updated: 2021-09-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2009-07-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Study Groups
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1
Combination of Bosutinib and Letrozole
Bosutinib
400mg (4x100)mg tablets once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs
Letrozole
2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs
2
Letrozole
Letrozole
2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs
Interventions
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Bosutinib
400mg (4x100)mg tablets once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs
Letrozole
2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs
Letrozole
2.5 mg - one tablet per day- once daily during the active phase of treatment until Disease Progression, unacceptable toxicity or withdraw of consents occurs
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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American Institute of Research
Whittier, California, United States
Joliet Oncology Hematology Associates
Joliet, Illinois, United States
Oncology Specialists SC
Niles, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
AZ Sint-Augustinus
Wilrijk, , Belgium
Cancer Hospital, Academy of Med Science and Peking Union Med
Beijing, Beijing Municipality, China
UNIMED Medical Institute
Hong Kong, , Hong Kong
Orszagos Onkologiai Intezet "B" Belgyogyaszati osztaly
Budapest, , Hungary
Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdr
Warsaw, , Poland
Johns Hopkins Singapore International Medical Centre
Singapore, , Singapore
Countries
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References
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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, Duvillie L, Lang 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.
Related Links
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Other Identifiers
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B1871010
Identifier Type: OTHER
Identifier Source: secondary_id
2008-006252-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3160A6-2207
Identifier Type: -
Identifier Source: org_study_id
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