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Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer

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ClinicalTrials.gov Identifier: NCT00079248
Recruitment Status : Unknown
Verified June 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : March 10, 2004
Last Update Posted : May 12, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Hormone replacement therapy may be effective in relieving symptoms of menopause, such as hot flashes, night sweats, and vaginal dryness, without causing a recurrence of breast cancer.

PURPOSE: This randomized clinical trial is studying hormone replacement therapy to see how well it works in relieving symptoms of menopause in postmenopausal women with previous stage I or stage II breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Hot Flashes Menopausal Symptoms Osteoporosis Biological: therapeutic progesterone Drug: conjugated estrogens Not Applicable

Detailed Description:


  • Compare disease-free survival and overall survival of postmenopausal women with prior stage I or II breast cancer treated with hormone replacement therapy (HRT) vs nonhormonal alternatives to HRT.
  • Compare relief of menopausal symptoms and quality of life of patients treated with these regimens.
  • Compare cardiovascular and osteoporotic events in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (< 40 years vs ≥ 40 years), and years from diagnosis (≤ 2 vs > 2 to < 5 vs ≥ 5). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral or transdermal HRT comprising estrogen with or without progesterone for at least 2 years.
  • Arm II: Patients are offered advice on nonhormonal HRT alternatives. Menopausal symptoms are assessed at baseline, at 3, 6, and 12 months, every 6 months for 4 years, and then annually thereafter. Quality of life is assessed at baseline, at 3, 6, and 12 months, every 6 months for 1 year, and then annually thereafter.

Patients are followed every 6 months for 3 years and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 2,800-3,000 patients (1,400-1,500 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer
Study Start Date : March 2002

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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


  • Prior diagnosis of stage I or II breast cancer

    • No clinical evidence of recurrence
  • Meets criteria for 1 of the following:

    • Amenorrheic for at least the past 6 months

      • Radiotherapy- or chemically-induced ovarian suppression allowed
    • Prior surgical bilateral oophorectomy
  • Experiencing vasomotor symptoms (i.e., hot flashes or night sweats) with or without vaginal dryness
  • No undiagnosed postmenopausal bleeding
  • No ductal carcinoma in situ or lobular carcinoma in situ alone
  • Hormone receptor status:

    • Not specified



  • Postmenopausal


  • Female

Menopausal status

  • Postmenopausal

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • No severe, active liver disease with abnormal liver function tests
  • No acute, intermittent porphyria
  • Fibrinolysis and coagulation normal


  • Not specified


  • No prior deep vein thrombosis

    • Thrombophlebitis or superficial phlebitis alone allowed
  • No prior retinal vein thrombosis


  • No prior pulmonary embolism


  • Not pregnant
  • No prior alcohol, drug, or chemical abuse
  • No other prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix


Biologic therapy

  • Not specified


  • No concurrent chemotherapy

Endocrine therapy

  • More than 3 months since prior oral or transdermal hormone replacement therapy (HRT)
  • More than 5 years since prior HRT implant
  • No other concurrent HRT
  • No concurrent gonadotropin-releasing hormone agonists (e.g., goserelin) if less than 2 years of planned treatment remains
  • No other concurrent low-dose progestins
  • No concurrent tibolone
  • No concurrent phytoestrogens (e.g., black cohosh, red clover, or soy)


  • See Disease Characteristics


  • See Disease Characteristics


  • No concurrent Hypericum perforatum (St. John's wort)

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 ClinicalTrials.gov identifier (NCT number): NCT00079248

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United Kingdom
Institute of Cancer Research - UK
Sutton, England, United Kingdom, SM2 5NG
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
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OverallOfficial: Jenni Parmar, RN Institute of Cancer Research, United Kingdom
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ClinicalTrials.gov Identifier: NCT00079248    
Other Study ID Numbers: CDR0000355122
First Posted: March 10, 2004    Key Record Dates
Last Update Posted: May 12, 2009
Last Verified: June 2005
Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
menopausal symptoms
hot flashes
Additional relevant MeSH terms:
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Breast Neoplasms
Hot Flashes
Neoplasms by Site
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Estrogens, Conjugated (USP)
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs