Home
Search
Study Topics
Glossary
|
Study 5 of 529 for search of: | Australia, Western Australia |
Previous Study | Return to Search Results | Next Study |
|
|
|
|
|
Sponsors and Collaborators: |
International Breast Cancer Study Group National Cancer Institute (NCI) Breast International Group Cancer and Leukemia Group B National Cancer Institute of Canada North Central Cancer Treatment Group National Surgical Adjuvant Breast and Bowel Project (NSABP) Southwest Oncology Group |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00066690 |
RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.
PURPOSE: This randomized phase III trial is studying ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: exemestane Drug: tamoxifen citrate Drug: triptorelin Procedure: adjuvant therapy Procedure: oophorectomy Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Trial Evaluating The Role Of Ovarian Function Suppression And The Role Of Exemestane As Adjuvant Therapies For Premenopausal Women With Endocrine Responsive Breast Cancer |
Estimated Enrollment: | 3000 |
Study Start Date: | August 2003 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, prior adjuvant/neoadjuvant chemotherapy (yes vs no), and number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more) and intented initial method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation) . Patients are randomized to 1 of 3 treatment arms.
Arm II: Patients receive tamoxifen as in arm I and ovarian function suppression by 1 of the following treatments:
Treatment continues for 5 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 3,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Completely resected disease
Prior surgery for primary breast cancer of 1 of the following types:
Total mastectomy with or without adjuvant radiotherapy
Tumor confined to the breast and axillary nodes
Axillary lymph node dissection or a negative axillary sentinel node biopsy required
No locally advanced inoperable breast cancer, including any of the following:
No prior ipsilateral or contralateral invasive breast cancer
Hormone receptor status:
Estrogen and/or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Premenopausal
Estradiol in the premenopausal range, unless the patient meets the following criteria within the past 6 months:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or bladder, contralateral or ipsilateral carcinoma in situ of the breast, or nonbreast invasive malignancy diagnosed at least 5 years ago without recurrence, including only the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
No concurrent oophorectomy unless performed as part of this study
Other
No concurrent bisphosphonates, except in the following cases:
Study Chair: | Prudence Francis, MD | Peter MacCallum Cancer Centre, Australia |
Study Chair: | Prudence Francis, MD | Peter MacCallum Cancer Centre, Australia |
Study Chair: | Gini F. Fleming, MD | University of Chicago |
Study Chair: | Barbara A. Walley, MD, FRCPC | Tom Baker Cancer Centre - Calgary |
Study Chair: | James N. Ingle, MD | Mayo Clinic |
Study Chair: | Charles E. Geyer, FACP, MD | Allegheny Cancer Center at Allegheny General Hospital |
Study Chair: | Silvana Martino, DO | John Wayne Cancer Institute at Saint John's Health Center |
Study ID Numbers: | CDR0000316456, IBCSG-2402, BIG-2-02, CALGB-IBCSG-2402, CAN-NCIC-IBCSG-2402, NCCTG-IBCSG-2402, NSABP-IBCSG-2402, SWOG-IBCSG-2402, NABCI-IBCSG-2402, UCLA-0403024-01, EU-20334, EUDRACT-2004-000166-13 |
Study First Received: | August 6, 2003 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00066690 |
Health Authority: | Unspecified |
stage I breast cancer stage II breast cancer stage IIIA breast cancer |
Skin Diseases Triptorelin Citric Acid Breast Neoplasms |
Exemestane Tamoxifen Breast Diseases |
Estrogen Antagonists Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Bone Density Conservation Agents Reproductive Control Agents Luteolytic Agents Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses Aromatase Inhibitors |