CompletedPhase 2

Raloxifene in Preventing Breast Cancer in Premenopausal Women

United StatesStarted 1998-12

Plain-language 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.

Who can participate

Age range

23 Years – 47 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Cardiova…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT00019500

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

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