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Raloxifene With or Without Exercise Compared With Exercise Alone in Women Who Have Been Previously Treated for Breast Cancer

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. Identifier: NCT00031811
Recruitment Status : Completed
First Posted : August 6, 2003
Last Update Posted : May 28, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

Brief Summary:

RATIONALE: Raloxifene and exercise may improve bone health and quality of life in breast cancer survivors. Assessing bone health and quality of life may improve the ability to plan treatment.

PURPOSE: Randomized clinical trial to study the effectiveness of raloxifene with or without exercise compared with exercise alone in women who have been previously treated for breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Menopausal Symptoms Osteoporosis Drug: raloxifene Procedure: quality-of-life assessment Not Applicable

Detailed Description:


  • Determine the effects of raloxifene with or without exercise versus exercise alone on bone reabsorption rate, bone formation rate, and bone density in women previously treated for breast cancer.
  • Determine the effects of these regimens on the quality of life of these patients.

OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are randomized to one of four treatment arms.

  • Arm I: Patients are asked to exercise 5 days a week with instruction. Patients also receive oral placebo once daily.
  • Arm II: Patients receive oral raloxifene once daily.
  • Arm III: Patients are asked to exercise as in arm I. Patients also receive oral raloxifene once daily.
  • Arm IV: Patients receive oral placebo once daily. All patients receive oral calcium supplements once daily. Treatment continues in all arms for 24 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and every 3 months during study.

PROJECTED ACCRUAL: A total of 240 patients (60 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: Breast Cancer Survivors: Exercise and Raloxifene
Study Start Date : March 2001
Actual Primary Completion Date : April 2003
Actual Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Raloxifene

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed breast cancer
  • No metastatic disease
  • At least 3 months but no more than 1 year since prior chemotherapy regimen including doxorubicin or methotrexate and catabolic steroids (to prevent nausea, vomiting, fluid retention, or hypersensitivity reactions)
  • No routine of regular strenuous exercise (more than 90 minutes per day 6 days/week OR 120 minutes per day 4 days/week)
  • Hormone receptor status:

    • Estrogen and progesterone receptor negative OR
    • Estrogen and progesterone receptor positive



  • Any age


  • Female

Menopausal status:

  • Postmenopausal (at diagnosis OR chemotherapy-induced)
  • No spontaneous menses for more than 6 months with increased follicle-stimulating hormone and decreased estradiol

Performance status:

  • Ambulatory

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No cardiac problems that would preclude exercise
  • No unstable angina


  • No respiratory problems that would preclude exercise
  • No chronic obstructive pulmonary disease
  • No oxygen dependence


  • No endocrine disease (e.g., parathyroid hormone disorders) that would accelerate bone turnover and loss
  • No musculoskeletal problems or other disease that would preclude exercise (e.g., movement-limiting arthritis, muscular dystrophy, or chronic fatigue syndrome)
  • No known cognitive or psychiatric disorders that would preclude study


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • Prior adjuvant or neoadjuvant chemotherapy allowed
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent tamoxifen


  • Prior adjuvant radiotherapy after chemotherapy allowed
  • No concurrent radiotherapy


  • Not specified


  • No concurrent bisphosphonates

Information from the National Library of Medicine

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 identifier (NCT number): NCT00031811

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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97201-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
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Study Chair: Anna Schwartz, FNP, PhD OHSU Knight Cancer Institute

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Responsible Party: OHSU Knight Cancer Institute Identifier: NCT00031811    
Other Study ID Numbers: CDR0000069229
OHSU-6312 ( Other Identifier: OHSU IRB )
First Posted: August 6, 2003    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: June 2010
Keywords provided by OHSU Knight Cancer Institute:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
menopausal symptoms
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic 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