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Sponsors and Collaborators: |
National Cancer Institute of Canada National Cancer Institute (NCI) North Central Cancer Treatment Group Cancer and Leukemia Group B Eastern Cooperative Oncology Group Southwest Oncology Group International Breast Cancer Study Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00066573 |
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy, using exemestane or anastrozole, may fight breast cancer by reducing the production of estrogen. It is not yet known whether exemestane is more effective than anastrozole in preventing the recurrence of breast cancer.
PURPOSE: This randomized phase III trial is studying exemestane to see how well it works compared to anastrozole in preventing cancer recurrence in postmenopausal women who have undergone surgery for primary breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: anastrozole Drug: exemestane Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Phase III Trial Of Exemestane Versus Anastrozole In Postmenopausal Women With Receptor Positive Primary Breast Cancer |
Estimated Enrollment: | 6840 |
Study Start Date: | June 2003 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lymph node status at diagnosis (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), and herceptin use (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 6 months during the first year of study participation and annually thereafter.
PROJECTED ACCRUAL: A total of 6,840 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
Completely resected disease
Primary surgery performed at least 3 weeks but no more than 3 months before study entry (if no chemotherapy was given)
No metastases confirmed by 1 of the following methods:
No prior or concurrent carcinoma in situ of the contralateral breast treated with partial mastectomy and/or hormonal therapy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal prior to chemotherapy, defined as 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No prior tamoxifen or other selective estrogen receptor modulators (SERMs) except raloxifene
At least 3 weeks since prior and no concurrent over-the-counter products or supplements considered to have an estrogenic effect, including any of the following:
No concurrent estrogens, progesterones, androgens, or SERMs
Radiotherapy
Surgery
Study Chair: | Paul E. Goss, MD, PhD | Massachusetts General Hospital |
Study Chair: | James N. Ingle, MD | Mayo Clinic |
Study Chair: | Matthew J. Ellis, MD, PhD, FRCP | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Study Chair: | George W. Sledge, MD | Indiana University Melvin and Bren Simon Cancer Center |
Study Chair: | George T. Budd, MD | The Cleveland Clinic |
Principal Investigator: | Manuela Rabaglio, MD | University Hospital Inselspital, Berne |
Study ID Numbers: | CDR0000316325, CAN-NCIC-MA27 (COMPANION), NCCTG-MA27, CALGB-CAN-NCIC-MA27, ECOG-CAN-NCIC-MA27, SWOG-CAN-NCIC-MA27, IBCSG-30-04, EUDRACT-2005-001893-28 |
Study First Received: | August 6, 2003 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00066573 |
Health Authority: | United States: Federal Government |
stage IIIA breast cancer stage I breast cancer stage II breast cancer |
Anastrozole Skin Diseases Breast Neoplasms Exemestane Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |