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AzTrials

Breast CancerPhase 2NCT00019500

Raloxifene in Preventing Breast Cancer in Premenopausal Women

A Phase 2 study testing raloxifene and evaluation of cancer risk factors in people with Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 23 to 47 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
raloxifene and evaluation of cancer risk factors
Type of treatment
Surgery or procedure
How many people
Not given
Where
1 siteUnited States
Study dates
Dec 1998to Jun 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 23 to 47 years
  • Women only
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medicine Branch

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Randomized Phase II Trial of Two Doses of Raloxifene in Pre-Menopausal Women at High Risk For Developing Invasive Breast Cancer

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.

Read the detailed description

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.

Conditions
Breast Cancer
Being tested
raloxifene, evaluation of cancer risk factors
Keywords
breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • raloxifeneDrug

  • evaluation of cancer risk factorsProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2005 (estimated)
  2. Study startDec 1998
  3. Study completionJun 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
IDs, dates and publications
ClinicalTrials.gov ID
NCT00019500
Sponsor's protocol ID
CDR0000066428
Other IDs
NCI-98-C-0123, MB-402
Status last verified
Apr 2009
First submitted
11 Jul 2001
Last updated
20 Jun 2013
Results posted
No

Publications

  • 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.

    PubMed 18583470

  • 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.

  • 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.

    PubMed 14693739

  • 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.

  • 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.

  • 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.

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing raloxifene and evaluation of cancer risk factors in people with Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00019500, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.

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