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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00253539 |
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. Estrogen can cause the growth of breast cancer cells. Hormone therapy using arzoxifene or tamoxifen may prevent breast cancer by lowering the amount of estrogen the body makes. The use of arzoxifene or tamoxifen may keep breast cancer from forming in women at high risk for breast cancer.
PURPOSE: This randomized phase II trial is studying arzoxifene to see how well it works compared to tamoxifen or a placebo in preventing breast cancer in premenopausal women at high risk for breast cancer.
Condition | Intervention | Phase |
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Breast Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2) |
Drug: arzoxifene hydrochloride Drug: placebo Drug: tamoxifen citrate |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase II Study of a Selective Estrogen Receptor Modulator (LY353381) vs. Tamoxifen vs. Placebo in Premenopausal Women With and Increased Risk for Breast Cancer |
Study Start Date: | January 2002 |
Primary Completion Date: | April 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Participants receive oral tamoxifen once daily for 6 months in the absence of disease progression or unacceptable toxicity. After the completion of 6 months of treatment, participants are offered the opportunity to continue treatment for an additional 6 months.
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Drug: tamoxifen citrate
Given orally
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Arm II: Experimental
Participants receive oral arzoxifene once daily for 6 months in the absence of disease progression or unacceptable toxicity. After the completion of 6 months of treatment, participants are offered the opportunity to continue treatment for an additional 6 months.
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Drug: arzoxifene hydrochloride
Given orally
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Arm III: Placebo Comparator
Participants receive an oral placebo once daily once daily for 6 months in the absence of disease progression or unacceptable toxicity. After the completion of 6 months of treatment, participants are offered treatment with arzoxifene for an additional 6 months.
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Drug: arzoxifene hydrochloride
Given orally
Drug: placebo
Given orally
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OBJECTIVES:
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Participants are randomized to 1 of 3 treatment arms.
After completion of study treatment, participants are followed annually.
PROJECTED ACCRUAL: A total of 120 participants will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Estimated probability of carrying a BRCA1 or BRCA2 mutation ≥ 10% AND meets one of the following criteria:
Participants must have first-degree relatives (FDRs)* or second-degree relatives (SDRs)* (with an intervening male relative) with breast or ovarian cancer who satisfy one of the following criteria:
High-risk breast/ovarian cancer (non-Jewish families)
Moderate-risk breast /ovarian cancer (non-Jewish families)
High-risk breast/ovarian cancer (Jewish families )
NOTE: **Age is approximated to the earliest age possible (e.g., a relative diagnosed in their 40's should be considered 40)
Participants not meeting any of the above FDR or SDR criteria may provide medical documentation stating that they, a FDR, or a SDR carry BRCA1 or BRCA2 mutations
No higher degrees of atypia beyond ASCUS on Pap smear
PATIENT CHARACTERISTICS:
Menopausal status
Premenopausal, as defined by 1 of the following:
Sex
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine Therapy
Radiotherapy
Surgery
Other
Study ID Numbers: | CDR0000449690, CASE-CCF-4713 |
Study First Received: | November 11, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00253539 |
Health Authority: | United States: Federal Government |
hereditary breast/ovarian cancer (BRCA1, BRCA2) breast cancer |
Ovarian cancer Ovarian Neoplasms Skin Diseases Gonadal Disorders Citric Acid Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases |
Urogenital Neoplasms Ovarian Diseases Tamoxifen Genital Diseases, Female Endocrinopathy Breast Diseases Endocrine Gland Neoplasms |
Estrogen Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Pharmacologic Actions Adnexal Diseases Estrogen Receptor Modulators Neoplasms Neoplasms by Site Therapeutic Uses |