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| Sponsor: | NCIC Clinical Trials Group |
|---|---|
| Collaborators: |
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 |
| Information provided by (Responsible Party): | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00066573 |
Purpose
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 |
|---|---|---|
|
Breast Cancer |
Drug: anastrozole Drug: exemestane |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Phase III Trial Of Exemestane Versus Anastrozole In Postmenopausal Women With Receptor Positive Primary Breast Cancer |
| Enrollment: | 7576 |
| Study Start Date: | June 2003 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral exemestane (25 mg) once daily for 5 years.
|
Drug: exemestane
Given orally
|
|
Active Comparator: Arm II
Patients receive oral anastrozole (1 mg) once daily for 5 years.
|
Drug: anastrozole
Given orally
|
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.
Eligibility| 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
Contacts and Locations
Show 39 Study Locations| 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 | Washington University Siteman Cancer Center |
| 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 |
More Information
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00066573 History of Changes |
| Obsolete Identifiers: | NCT00438529 |
| Other Study ID Numbers: | MA27, CAN-NCIC-MA27, NCCTG-MA27, CALGB-CAN-NCIC-MA27, ECOG-CAN-NCIC-MA27, SWOG-CAN-NCIC-MA27, IBCSG-30-04, EUDRACT-2005-001893-28, CDR0000316325 |
| Study First Received: | August 6, 2003 |
| Last Updated: | September 30, 2011 |
| Health Authority: | Canada: Health Canada; United States: Food and Drug Administration |
|
stage IIIA breast cancer stage I breast cancer stage II breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Exemestane Anastrozole |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal |