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Sponsors and Collaborators: |
Oregon Health and Science University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00722072 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving sorafenib together with fulvestrant may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sorafenib together with fulvestrant works in treating patients with locally advanced or metastatic breast cancer that did not respond to aromatase inhibitor therapy.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: fulvestrant Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Open-Label Study of Sorafenib Plus Fulvestrant as Salvage Therapy for Hormone Receptor Positive Metastatic Breast Cancer Failing Prior Aromatase Inhibitor Treatment |
Estimated Enrollment: | 43 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Patients also receive fulvestrant intramuscularly on days 1 and 15 of course
1 and on day 1 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 28-56 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of incurable breast cancer
Measurable or evaluable disease
Measurable disease is defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
Evaluable disease includes unresectable skin/chest wall metastases that can be photographed and whose size can be measured with a ruler
Previously treated with a third-generation aromatase inhibitor (e.g., letrozole, anastrazole, or exemestane) AND meets one of the following criteria:
HER2/neu-negative tumor
Hormone receptor status:
PATIENT CHARACTERISTICS:
No cardiac disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Oregon | |
Knight Cancer Institute at Oregon Health and Science University | Recruiting |
Portland, Oregon, United States, 97239-3098 | |
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu |
Principal Investigator: | Stephen Chui, MD | Oregon Health and Science University |
Responsible Party: | Knight Cancer Institute at Oregon Health and Science University ( Stephen Chui ) |
Study ID Numbers: | CDR0000601002, OHSU-4318, BAYER-OHSU-4318 |
Study First Received: | July 24, 2008 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00722072 History of Changes |
Health Authority: | Unspecified |
male breast cancer stage IIIA breast cancer stage IIIB breast cancer |
stage IIIC breast cancer stage IV breast cancer recurrent breast cancer |
Estrogens Estrogen Antagonists Antineoplastic Agents, Hormonal Skin Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Fulvestrant Breast Neoplasms Breast Cancer, Male |
Protein Kinase Inhibitors Hormones Recurrence Estrogen Receptor Modulators Breast Neoplasms, Male Aromatase Inhibitors Sorafenib Breast Diseases |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Skin Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Fulvestrant Breast Neoplasms |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors Sorafenib Breast Diseases |