Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
This trial is active, not recruiting.
|Condition||metastatic breast cancer|
|Phase||phase 1/phase 2|
|Targets||RAF, FLT-3, KIT, PDGF, VEGF|
|Sponsor||Rutgers, The State University of New Jersey|
|Collaborator||Rutgers Cancer Institute of New Jersey|
|Start date||August 2008|
|End date||May 2017|
|Trial size||54 participants|
|Trial identifier||NCT00634634, 0220070284, 040706, NCI-2012-00525, NJ 1107|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Washington DC, DC||Georgetown University Hospital||no longer recruiting|
|Atlanta, GA||Emory University||no longer recruiting|
|New Brunswick, NJ||Rutgers Cancer Institute of New Jersey||no longer recruiting|
|Voorhees, NJ||Cooper Hospital/University Medical Center||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
find phase II dose of study drugs in pts w/hormone receptor-positive locally advanced or metastatic breast ca. find clinical benefit rate (pts who achieve a CR, PR, or SD in the first-line trt of postmenopausal pts.
time frame: 3 years
time to progression/survival. Assess safety/tolerability. Evaluate growth factor pathways in tumor samples before/after trt. Evaluate change in circulating tumor cells before/after trt. Evaluate change in blood flow before/after treatment
time frame: 3 years
Female participants at least 18 years old.
Inclusion Criteria: 1. Histologically confirmed invasive breast cancer 2. Stage IIIB, IIIC with T4 lesion or Stage IV disease 3. Breast cancer must be ER-positive and/or PR-positive 4. Age ³ 18 years of age 5. ECOG performance status 0, 1 or 2 6. Able to swallow and oral medication 7. Adequate end organ function 8. Written informed consent Exclusion Criteria: 1. Prior hormonal therapy for metastatic disease 2. Prior chemotherapy for metastatic disease 3. Prior treatment with sorafenib 4. Brain metastases or leptomeningeal disease 5. Evidence or history of bleeding 6. Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
|Official title||Phase I/II Trial of Letrozole (Femara) and Sorafenib (Nexavar) in Postmenopausal Women With Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer|
|Principal investigator||Antoinette Tan, MD|
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