Study of Tamoxifen and Raloxifene (STAR) for the Prevention of Breast Cancer in Postmenopausal Women

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Tamoxifen; Drug: Raloxifene

• Registration Number: NCT00003906
• Lead Sponsor: NSABP Foundation Inc

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using raloxifene and tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.

PURPOSE: Randomized double-blinded clinical trial to compare the effectiveness of raloxifene with that of tamoxifen in preventing breast cancer in postmenopausal women.

Detailed Description

OBJECTIVES:

* Determine whether raloxifene is more or less effective than tamoxifen in significantly reducing the incidence rate of invasive breast cancer in postmenopausal women.

* Evaluate the effects of tamoxifen and raloxifene on the incidence of intraductal carcinoma in situ, lobular carcinoma in situ, endometrial cancer, ischemic heart disease, fractures of the hip and spine, or Colles' fractures of the wrist in these participants.

* Evaluate the toxic effects of these regimens in these participants.

* Determine the effect of these regimens on the quality of life of these participants (at selected centers). (Quality of life evaluation closed to accrual effective 5/31/01.)

OUTLINE: This is a randomized, double-blind study. Participants are stratified by age (35 to 49 vs 50 to 59 vs over 59), race (black vs white vs other), history of lobular carcinoma in situ (yes vs no), prior hysterectomy (yes vs no), and estimated absolute risk of invasive breast cancer within 5 years (using the Gail model)(less than 2.0 vs 2.0-2.9 vs 3.0-4.9 vs 5.0 or greater). Participants are randomized to 1 of 2 arms.

* Arm I: Participants receive oral tamoxifen plus placebo daily for 5 years.

* Arm II: Participants receive oral raloxifene plus placebo daily for 5 years. Quality of life is assessed (at selected centers) at baseline and at 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 72 months. (Quality of life evaluation closed to accrual effective 5/31/01.)

Participants are followed annually after 5 years.

PROJECTED ACCRUAL: Approximately 19,000 participants will be accrued for this study within 5 years.

Study Timeline

• Study Start: 1999-05
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-12
• Study Completion: 2012-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19747

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Tamoxifen	Tamoxifen and placebo
Group 2	Raloxifene	Raloxifene and Placebo

Primary Outcome Measures

Name	Time	Method
Incidence of invasive breast cancer; superiority of one of the therapies.	Time from randomization to the occurance of invasive breast cancer.	Determine which of the following is true: 1. compared to tamoxifen, raloxifene significantly reduces the incidence rate of invasive breast cancer; 2. compared to raloxifene, tamoxifen significantly reduces the incidence rate of invasive breast cancer; or; 3. the statistical superiority of one of the treatments cannot be demonstrated and the choice of therapy should be based on benefit/risk considerations.

Secondary Outcome Measures

Name	Time	Method
Effect of the study therapies on the incidence of intraductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS).	Time from randomization to the occurance of DCIS or LCIS.
Effect of the study therapies on the incidence of endometrial cancer.	Time from randomization to the occurance of endometrial cancer.
Effect of the study therapies on the incidence of fractures of the hip, spine, or Colles' fractures of the wrist.	Time from randomization to the occurance of fractures of the hip, spine, or Colles' fractures of the wrist.
Effect of the study therapies on the incidence of ischemic heart disease.	Time from randomization to the occurance of ischimic heart disease.
Effect of the study therapies on the toxicity and side effects of each therapy.	Incidences of protocol defined toxicities and side effects.
Effect of the study therapies on participants' quality of life.	pre-entry, every 6 months for 5 years, and then annual after 5 years following randomization.

Trial Locations

Locations (516)

Comprehensive Cancer Institute; 🇺🇸 Huntsville, Alabama, United States

MBCCOP - Gulf Coast; 🇺🇸 Mobile, Alabama, United States

Providence Alaska Medical Center; 🇺🇸 Anchorage, Alaska, United States

CCOP - Western Regional, Arizona; 🇺🇸 Phoenix, Arizona, United States

CCOP - Mayo Clinic Scottsdale Oncology Program; 🇺🇸 Scottsdale, Arizona, United States

Arizona Cancer Center at University of Arizona Health Sciences Center; 🇺🇸 Tucson, Arizona, United States

Breast Associates; 🇺🇸 Fayetteville, Arkansas, United States

Surgical Associates; 🇺🇸 Fort Smith, Arkansas, United States

Northeast Arkansas Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

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