Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
Study Details
Study Description
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 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Sorafenib and Letrozole
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Drug: Sorafenib
sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
Other Names:
Drug: Letrozole
Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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. [3 years]
Secondary Outcome Measures
- 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 [3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed invasive breast cancer
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Stage IIIB, IIIC with T4 lesion or Stage IV disease
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Breast cancer must be ER-positive and/or PR-positive
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Age ³ 18 years of age
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ECOG performance status 0, 1 or 2
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Able to swallow and oral medication
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Adequate end organ function
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Written informed consent
Exclusion Criteria:
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Prior hormonal therapy for metastatic disease
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Prior chemotherapy for metastatic disease
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Prior treatment with sorafenib
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Brain metastases or leptomeningeal disease
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Evidence or history of bleeding
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Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Georgetown University Hospital | Washington | 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 | New Jersey | United States | 08690 |
Sponsors and Collaborators
- Rutgers, The State University of New Jersey
- Rutgers Cancer Institute of New Jersey
- National Cancer Institute (NCI)
- Bayer
- Novartis Pharmaceuticals
Investigators
- Principal Investigator: Antoinette Tan, MD, Rutgers Cancer Institute of New Jersey
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0220070284/Pro2018001861
- NJ 1107
- 0220070284
- NCI-2012-00525
- 040706
- Pro2018001861