Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer.
PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.
- Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen.
OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years.
Patients are followed annually.
PROJECTED ACCRUAL: Approximately 20,000 patients will be accrued for this study.
Allocation: Randomized, Control: Active Control, Primary Purpose: Treatment
tamoxifen citrate, adjuvant therapy
Atlas Trial Office
Active, not recruiting
National Cancer Institute (NCI)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00003016
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. PURPOSE: Phase III trial t...
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Studyin...
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known if...
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is no...
The purpose of this study is to determine whether 6 years adjuvant anastrozole will improve the disease free survival compared to 3 years adjuvant anastrozole in postmenopausal hormone sen...
Comparison of the prognostic and predictive utilities of the 21-gene Recurrence Score assay and Adjuvant! for women with node-negative, ER-positive breast cancer: results from NSABP B-14 and NSABP B-20.
The Oncotype DX(®) Recurrence Score(®) (RS) is a validated genomic predictor of outcome and response to adjuvant chemotherapy in ER-positive breast cancer. Adjuvant! was developed using SEER registr...
ABSTRACT: BACKGROUND: Adult granulosa cell tumor associated with antecedent use of tamoxifen as adjuvant hormonotherapy for breast cancer is rare. The pathogenesis of this occurrence remains difficult...
ABSTRACT: INTRODUCTION: The HOXB13:IL17BR index has been identified to predict clinical outcome in the setting of adjuvant tamoxifen monotherapy of breast cancer. Further studies have shown that HOXB1...
PURPOSE: Tamoxifen is used in the treatment of breast cancer to prevent recurrences. It is converted to its active metabolite endoxifen by CYP2D6 enzyme. This study was conducted to evaluate the influ...
Health-related quality of life, psychological distress, and adverse events in postmenopausal women with breast cancer who receive tamoxifen, exemestane, or anastrozole as adjuvant endocrine therapy: National Surgical Adjuvant Study of Breast Cancer 04 (N-
Health-related quality of life (HRQOL), symptoms of depression, and adverse events (AEs) were compared between Japanese postmenopausal patients with hormone-sensitive breast cancer (BC) who received a...