Breast Cancer Clinical Trial

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Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer

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Summary

Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.

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Eligibility Criteria

Inclusion Criteria:

Histologically confirmed invasive breast cancer
Stage IIIB, IIIC with T4 lesion or Stage IV disease
Breast cancer must be ER-positive and/or PR-positive
Age ³ 18 years of age
ECOG performance status 0, 1 or 2
Able to swallow and oral medication
Adequate end organ function
Written informed consent

Exclusion Criteria:

Prior hormonal therapy for metastatic disease
Prior chemotherapy for metastatic disease
Prior treatment with sorafenib
Brain metastases or leptomeningeal disease
Evidence or history of bleeding
Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT00634634

Recruitment Status:

Terminated

Sponsor:

Rutgers, The State University of New Jersey

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There are 4 Locations for this study

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Georgetown University Hospital
Washington District of Columbia, 20007, United States
Emory University
Atlanta Georgia, 30322, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Cooper Hospital/University Medical Center
Voorhees New Jersey, 08690, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

54

Study ID:

NCT00634634

Recruitment Status:

Terminated

Sponsor:


Rutgers, The State University of New Jersey

How clear is this clinincal trial information?

Clinical Trial Resources

SurvivorNet’s Guide To Clinical Trials: What Are They And Are They Right for You?
Clinical Trials for Breast Cancer
Have You Been Diagnosed With Late-Stage Breast Cancer? Know That You Have Treatment Options.
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