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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002777 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane or tamoxifen may fight cancer by blocking the uptake of estrogen.
PURPOSE: Randomized phase II/III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have locally recurrent or metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: exemestane Drug: tamoxifen citrate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | RANDOMIZED PHASE II STUDY IN FIRST LINE HORMONAL TREATMENT FOR METASTATIC BREAST CANCER WITH EXEMESTANE OR TAMOXIFEN IN POSTMENOPAUSAL PATIENTS |
Estimated Enrollment: | 342 |
Study Start Date: | May 1996 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. (Phase II of this study closed as of 6/14/00). Patients are stratified by participating center, prior adjuvant tamoxifen (yes vs no), prior chemotherapy for metastatic disease (yes vs no), and dominant site of metastasis (visceral with or without others vs bone only vs bone and soft tissue vs soft tissue only).
Patients are randomized to receive either oral exemestane or oral tamoxifen daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 18 months and then at least every 6 months thereafter.
PROJECTED ACCRUAL: A total of 342 patients will be accrued for this study within 4.7 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least one bidimensionally measurable or evaluable lesion
The following are not considered evaluable:
Hormone receptor status:
Estrogen receptor positive or progesterone receptor positive, defined by 1 of the following:
Unknown receptor status eligible provided:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Postmenopausal by 1 of the following:
Chemotherapy induced menopause if:
Surgical castration
Performance status:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Robert Paridaens, MD, PhD | U.Z. Gasthuisberg |
Study ID Numbers: | CDR0000064764, EORTC-10951, PHARMACIA-EORTC-10951 |
Study First Received: | November 1, 1999 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00002777 |
Health Authority: | United States: Federal Government |
stage IV breast cancer recurrent breast cancer |
Skin Diseases Citric Acid Breast Neoplasms Exemestane |
Tamoxifen Breast Diseases Recurrence |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Bone Density Conservation Agents Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors |