Raloxifene in Preventing Breast Cancer in Premenopausal Women

NCT00019500 | Completed Phase 2

• 3 other identifiers: CDR0000066428NCI-98-C-0123MB-402
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of raloxifene may be an effective way to prevent breast cancer in premenopausal women. PURPOSE: Phase II trial to study the effectiveness of raloxifene in preventing invasive breast cancer in premenopausal women.

Conditions

Breast Cancer

Keywords

breast cancer

Interventions

raloxifene DRUG

evaluation of cancer risk factors PROCEDURE

Eligibility Criteria

• Age: 23 Years - 47 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * At risk for developing invasive breast cancer by virtue of 1 of the following criteria: * Gail model risk equal to that of an average 60 year old woman as determined using the Gail risk assessment model * Lobular neoplasia * Atypical ductal hyperplasia with a positive family history of breast cancer * Ductal carcinoma in situ previously treated with mastectomy or lumpectomy and radiation * BRCA1 or BRCA2 mutation-positive genotyping * Family history consistent with hereditary cancer syndrome of increased breast cancer risk defined as 1 of the following: * Family with more than 2 breast cancer cases and one or more cases of ovarian cancer diagnosed at any age * Family with more than 3 breast cancer cases diagnosed before age 50 * Sister pairs with 2 breast cancers, 2 ovarian cancers, or 1 breast and 1 ovarian cancer diagnosed before age 50 * Premenopausal * Menstrual cycle of 26-35 days * No change in menstrual pattern within the past 6 months (no irregularities) * FSH level less than 20 mIU/mL * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 23 to 47 Sex * Female Menopausal status * Premenopausal Performance status * Not specified Life expectancy * Not specified Hematopoietic * No history of bleeding disorder Hepatic * No history of cirrhosis of the liver * SGOT/SGPT no greater than 3 times upper limit of normal (ULN) Renal * Creatinine no greater than 1.7 mg/dL Cardiovascular * No history of pulmonary embolism or deep venous thrombosis Other * Not pregnant or nursing * Negative pregnancy test * Fertile participants must use effective non-hormonal contraception (e.g. barrier methods, spermicides, or surgical methods) during and for 3 months after study * No history of infertility with a suspected ovarian etiology or recurrent ovarian cysts * No allergy to raloxifene * No dysfunctional uterine bleeding * No menorrhagia * No cervical dysplasia or significant uterine pathology requiring concurrent surgery * No medical or psychiatric disorder that would preclude study participation * Normal CA 125 levels PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * At least 6 months since prior steroid therapy (e.g., tamoxifen, estrogen, DHEA, anabolic steroids, or oral contraceptives) Radiotherapy * See Disease Characteristics Surgery * See Disease Characteristics * No prior hysterectomy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Medicine Branch

Bethesda, Maryland, 20892, United States

Location

Related Publications (7)

• Eng-Wong J, Orzano-Birgani J, Chow CK, Venzon D, Yao J, Galbo CE, Zujewski JA, Prindiville S. Effect of raloxifene on mammographic density and breast magnetic resonance imaging in premenopausal women at increased risk for breast cancer. Cancer Epidemiol Biomarkers Prev. 2008 Jul;17(7):1696-701. doi: 10.1158/1055-9965.EPI-07-2752. Epub 2008 Jun 26.

  PMID: 18583470 RESULT

• 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.

  RESULT

• 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 Biomarkers Prev. 2003 Dec;12(12):1468-73.

  PMID: 14693739 RESULT

• 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 Prevention Research, October 26 - 30, 2003, Phoenix, AZ. 12: A-193, 1300s, 2003.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jennifer Eng-Wong, MD

  National Cancer Institute (NCI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: June 23, 2005
• Study Start: December 1, 1998
• Study Completion: June 1, 2005
• Last Updated: June 20, 2013

Record last verified: 2009-04

Locations

US (1)