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Sponsors and Collaborators: |
Albert Einstein College of Medicine of Yeshiva University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082810 |
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen. Combining tipifarnib with fulvestrant may kill tumor cells that did not respond to first-line therapy.
PURPOSE: This phase II trial is studying how well giving tipifarnib together with fulvestrant works as second-line therapy in treating postmenopausal women with hormone receptor-positive inoperable locally advanced or metastatic breast cancer that has progressed after previous first-line endocrine therapy.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: fulvestrant Drug: tipifarnib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Tipifarnib (R115777, Zarnestra™) in Combination With Fulvestrant (Faslodex®) in Postmenopausal Hormone Receptor-Positive Breast Cancer Patients Who Have Progressive Disease After First-Line Endocrine Therapy |
Estimated Enrollment: | 45 |
Study Start Date: | May 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive fulvestrant intramuscularly on day 1 and oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity*.
NOTE: *Fulvestrant continues even if tipifarnib is held for toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the breast of 1 of the following stages:
Progressive disease, defined by 1 of the following:
No rapidly progressive, life-threatening metastases, including any of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, defined as 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior chemotherapy for metastatic disease
Endocrine therapy
At least 28 days since prior fulvestrant
Radiotherapy
Surgery
Other
No other concurrent anticancer treatment
United States, New York | |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 | |
Beth Israel Medical Center - Petrie Division | |
New York, New York, United States, 10003-3803 | |
Mount Sinai Medical Center | |
New York, New York, United States, 10029 | |
St. Luke's-Roosevelt Hospital Center - Roosevelt Division | |
New York, New York, United States, 10019 | |
North Shore University Hospital | |
Manhasset, New York, United States, 11030 | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 |
Study Chair: | Linda T. Vahdat, MD | Weill Medical College of Cornell University |
Study ID Numbers: | CDR0000360837, AECM-0104-085, NCI-6205 |
Study First Received: | May 14, 2004 |
Last Updated: | June 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00082810 History of Changes |
Health Authority: | United States: Federal Government |
recurrent breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Estrogens Estrogen Antagonists Skin Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Fulvestrant Hormones, Hormone Substitutes, and Hormone Antagonists |
Breast Neoplasms Hormones Recurrence Estrogen Receptor Modulators Breast Diseases Tipifarnib |
Estrogen Antagonists Antineoplastic Agents, Hormonal Skin Diseases Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Fulvestrant |
Breast Neoplasms Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases Tipifarnib |