Raloxifene in Preventing Breast Cancer in Premenopausal Women
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00019500 |
Recruitment Status :
Completed
First Posted : June 23, 2005
Last Update Posted : June 20, 2013
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: raloxifene Procedure: evaluation of cancer risk factors | Phase 2 |
OBJECTIVES:
- Determine the safety and tolerability of raloxifene in premenopausal women at high risk of developing invasive breast cancer.
- Determine the effect of raloxifene on blood steroid hormone levels (luteinizing hormone, estradiol, progesterone) and carotenoid levels during the menstrual cycle in these participants.
- Determine the effect of raloxifene on the endometrium and ovaries in these participants.
- Determine the effect of raloxifene on biochemical markers of bone metabolism, lipid profiles, and fibrinogen in these participants.
- Determine the effect of raloxifene on health-related quality of life of these participants.
- Determine the effect of raloxifene on bone mineral density in the spine and hip of these participants.
OUTLINE: This is an open-label study.
Participants are medically evaluated, followed by an observation period of 1 to 2 menstrual cycles. After the observation period, participants receive oral raloxifene once daily for 2 years.
Quality of life is assessed 1 week prior to study drug administration and at 6, 12, 24 and 36 months after study drug administration.
Participants are followed for 1 year.
PROJECTED ACCRUAL: A total of 41 participants will be accrued for this study within 3 years.
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Prevention |
Official Title: | A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer |
Study Start Date : | December 1998 |
Actual Study Completion Date : | June 2005 |


Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 23 Years to 47 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019500
United States, Maryland | |
Medicine Branch | |
Bethesda, Maryland, United States, 20892 |
Study Chair: | Jennifer Eng-Wong, MD | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019500 |
Obsolete Identifiers: | NCT00001700 |
Other Study ID Numbers: |
CDR0000066428 NCI-98-C-0123 MB-402 |
First Posted: | June 23, 2005 Key Record Dates |
Last Update Posted: | June 20, 2013 |
Last Verified: | April 2009 |
breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Raloxifene Hydrochloride Estrogen Antagonists |
Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents |