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

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Whittier, California, 90603 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

- 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.

NCT00880009
Pfizer
Terminated
Study Evaluating Bosutinib-Letrozole Combination Versus Letrozole Alone In Post Menopausal Women With Breast Cancer

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now