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| Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00060177 |
Purpose
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. Combining tipifarnib with letrozole may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of letrozole with or without tipifarnib in treating women with locally advanced, locally recurrent, or metastatic breast cancer that has progressed after antiestrogen therapy.
| Condition | Intervention | Phase |
|
Breast Cancer |
Drug: letrozole Drug: tipifarnib |
Phase II |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| ChemIDplus related topics: | Letrozole Tipifarnib |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | A Randomized, Blinded, Phase 2 Study of Letrozole Plus the Farnesyl Transferase Inhibitor ZARNESTRA (R115777) and Letrozole Plus Placebo in the Treatment of Advanced Breast Cancer After Antiestrogen Therapy |
| Study Start Date: | January 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Courses in both arms repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 30-42 days and every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 120 patients (40 for arm I and 80 for arm II) will be accrued for this study.
Eligibility
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed breast cancer in 1 of the following disease states:
Documented disease progression on or after antiestrogen therapy, given in 1 of the following ways:
Measurable disease
No rapidly progressive, life-threatening metastases, including:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, defined as any of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Ohio | |||||
| Ireland Cancer Center | |||||
| Cleveland, Ohio, United States, 44106-5065 | |||||
| Ireland Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Paula Silverman, MD | Case Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000299534, CWRU-JJPR-1102, JJPRD-R115777-INT-22 |
| First Received: | May 6, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00060177 |
| Health Authority: | United States: Federal Government |
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