Status:
COMPLETED
Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
Rutgers Cancer Institute of New Jersey
National Cancer Institute (NCI)
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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 breas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 11 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00634634
Start Date
August 11 2008
End Date
April 28 2023
Last Update
November 9 2023
Active Locations (4)
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1
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
2
Emory University
Atlanta, Georgia, United States, 30322
3
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
4
Cooper Hospital/University Medical Center
Voorhees Township, New Jersey, United States, 08690