Breast Cancer — Raloxifene in Preventing Breast Cancer in Premenopausal Women
Citation(s)
Eng-Wong J, Hursting SD, Venzon D, Perkins SN, Zujewski JA Effect of raloxifene on insulin-like growth factor-I, insulin-like growth factor binding protein-3, and leptin in premenopausal women at high risk for developing breast cancer. Cancer Epidemiol B
Eng-Wong J, Stratton P, Forman M, et al : Effect of raloxifene on menstrual cycle length and quality of life in premenopausal women at high risk for invasive breast cancer. [Abstract] American Association for Cancer Research: Frontiers in Cancer Preventio
Eng-Wong J, Venzon D, Schmidt B, et al : The effect of raloxifene on insulin-like growth factor-1 (IGF-1) and insuline-like growth factor binding protein-3 (IGFBP-3) in premenopausal women at high risk for developing breast cancer. [Abstract] American Ass
Orzano JA, Prindiville S, Zujewski J, et al : Mammographic density is not modulated by raloxifene in pre-menopausal women at high-risk for invasive breast cancer. [Abstract] Breast Cancer Res Treat 88 (Suppl 1): A-4035, 2004.
Premkumar A, Stratton P, Avila N, et al : Raloxifene effects on the ovary and the uterus in premenopausal subjects at high risk for developing breast cancer - sonographic evaluation. [Abstract] Ultrasound Obstet Gynecol 20 (Supp 1): A-P174, 72, 2002.
Premkumar A, Stratton P, Johnson D, et al : Long term effects of raloxifene on the ovary and uterus in pre-menopausal women at high risk for developing breast cancer. [Abstract] Ultrasound Obstet Gynecol 22 (Suppl 1): A-OC164, 44, 2003.
Zujewski J, Eng-Wong J, Reynolds J, et al : A phase 2 trial of raloxifene in premenopausal women at high risk for developing invasive breast cancer. [Abstract] Breast Cancer Res Treat 76 (Suppl 1): A-417, 2002.
A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
