Track topics on Twitter Track topics that are important to you
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combining chemotherapy with hormone therapy may kill more tumor cells. Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of fenretinide may be an effective way to prevent the recurrence of breast cancer. It is not yet known whether tamoxifen plus fenretinide is more effective than tamoxifen alone for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen plus fenretinide with tamoxifen alone in treating postmenopausal women who have stage II or stage III breast cancer that is estrogen receptor positive and/or progesterone receptor positive.
OBJECTIVES: I. Compare disease free survival and overall survival of postmenopausal women with stage II or IIIA breast cancer treated with tamoxifen (TMX) and fenretinide (HPR) vs TMX and placebo. II. Gain wider experience in the use and toxicity of combined TMX/HPR in these patients. III. Obtain tumor tissue samples, as feasible, from these patients for future biologic studies.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified by participating institution, age (under 70 vs 70 and over), node dissection (yes vs no), number of involved nodes (0 vs 1-3 vs 4 or more), and number of removed nodes (1-5 vs 6 or more). All patients receive oral tamoxifen daily for at least 5 years, beginning immediately after randomization. Patients also receive either oral fenretinide or oral placebo daily for 5 years, beginning within 2 weeks after completion of any radiotherapy, or within 2 weeks of randomization, if no radiation. Patients are followed during and after treatment every 4 months for 2 years, every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for this study over approximately 3 years.
Allocation: Randomized, Primary Purpose: Treatment
fenretinide, tamoxifen citrate
MBCCOP - University of South Alabama
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:59:02-0400
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...
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 This phase IIb tri...
This randomized phase III trial studies tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating wom...
RATIONALE: Estrogen can cause the growth of breast cancer cells. Aromatase inhibitors, such as letrozole, anastrozole, and exemestane, may fight breast cancer by lowering the amount of est...
This randomized clinical trial studies tamoxifen citrate in treating premenopausal women with estrogen receptor (ER)-positive breast cancer. Estrogen can cause the growth of breast cancer ...
Raloxifene and tamoxifen are FDA approved for breast cancer risk reduction; in 2013, the US Preventive Services Task Force (USPSTF) recommended these drugs for breast cancer risk reduction in high-ris...
Breast cancer is the most common malignancy in women worldwide. Recurrence rates in breast cancer are considered to be dependent on the serum concentration of endoxifen, the active metabolite of tamox...
Tamoxifen is frequently prescribed to prevent breast cancer recurrence. Tamoxifen is a prodrug and requires bioactivation by CYP2D6. Tamoxifen use is often limited by adverse effects including severe ...
Glutathione S-transferase mu 3 (GSTM3) is an enzyme involving in the detoxification of electrophilic compounds by conjugation with glutathione. Higher GSTM3 mRNA levels were reported in patients with ...
Long noncoding RNAs (lncRNAs) work as oncogenes or tumor suppressors that play important roles in tumorigenesis and chemotherapeutic drug resistance. This study investigates the role of lncRNA growth ...
A synthetic retinoid that is used orally as a chemopreventive against prostate cancer and in women at risk of developing contralateral breast cancer. It is also effective as an antineoplastic agent.
Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).
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)
A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
Diabetes Diabetes Endocrine Obesity Oxycontin Renal Disease Thyroid Disorders Endocrinology is the study of the endocrine glands and the hormones that they secrete (Oxford Medical Dictionary). There are several groups of h...
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...