Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00880009

Run by

Pfizer

People needed

16

Starts

2009-07-30

Expected to finish

2010-05-31

Last updated by the study team

2021-09-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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