Status:
COMPLETED
Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Pharmacia
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this research study is to learn about the effects of two drugs when they are given together. The names of the drugs are raloxifene and exemestane. Raloxifene is a drug that is related ...
Detailed Description
The objectives of this project are to investigate the safety and toxicity of the combination of raloxifene, a selective estrogen receptor modulator (SERM), with exemestane, a new steroidal aromatase i...
Eligibility Criteria
Inclusion
- Postmenopausal women with a history of AJCC Stage 0, I, II or III breast cancer, with no clinical evidence of disease, after completion of all planned adjuvant therapy. Patients must not have received anti-estrogen therapy as part of their adjuvant treatment. Patients with a history of invasive ER- and/or PR-positive breast cancer are eligible only if they have not received an anti-estrogen as part of adjuvant therapy, and they are at least 2 years from the time of their primary surgery.
- Patients must have completed all planned adjuvant therapy, including surgery, chemotherapy, and radiation therapy, at least 4 weeks prior to treatment. There is no limit as to the amount of time that may have passed since completion of adjuvant therapy and initiation of treatment.
- Patients must be postmenopausal, as defined by either:
- No spontaneous menses for at least 5 years; women who have had a hysterectomy in this group, but have intact ovaries must have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the postmenopausal range
- Spontaneous menses within the past 5 years, but amenorrheic (e.g. spontaneous or secondary to chemotherapy, radiation therapy or hysterectomy) for at least 12 months, and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the postmenopausal range
- Bilateral oophorectomy
- Patients must have a history of breast cancer confirmed by the Department of Pathology at Memorial Sloan-Kettering Cancer Center.
- Patients must be at least 18 years old, and must be able to give written informed consent.
- Karnofsky performance status \> 80%.
- Laboratory parameters:
- WBC =\>3.0 x 106 cells/ml serum bilirubin \<= 1.5 mg/dl serum creatinine \<= 1.5 mg/dl serum AST (SGOT) \<= 2x upper institutional normal CEA and CA15-3 within institutional normal limits
Exclusion
- Prior history of bilateral mastectomy.
- Prior history of ovarian or endometrial cancer.
- Prior or current history of osteoporosis, as defined by a lumbar-spine bone mineral density \< 2.5 SD below the mean value for normal premenopausal women.
- Use of bisphosphonates or calcitonin within the past 3 months.
- Prior history of venous thrombosis or pulmonary embolism.
- Patients with unstable angina or New York Heart Association Class III or IV heart disease.
- Prior hormonal therapy within the past 3 months.
Key Trial Info
Start Date :
July 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00200174
Start Date
July 1 1999
End Date
August 1 2008
Last Update
July 5 2023
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021