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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 8, 2004
First Posted Date  ICMJE March 10, 2004
Last Update Posted Date May 12, 2009
Study Start Date  ICMJE March 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer
Official Title  ICMJE UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer
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.

Detailed Description

OBJECTIVES:

  • 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Hot Flashes
  • Menopausal Symptoms
  • Osteoporosis
Intervention  ICMJE
  • Biological: therapeutic progesterone
  • Drug: conjugated estrogens
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Postmenopausal

Sex

  • Female

Menopausal status

  • Postmenopausal

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

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

Renal

  • Not specified

Cardiovascular

  • No prior deep vein thrombosis

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

Pulmonary

  • No prior pulmonary embolism

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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)

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics

Other

  • No concurrent Hypericum perforatum (St. John's wort)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00079248
Other Study ID Numbers  ICMJE CDR0000355122
CRUK-HRT
EU-20112
ISRCTN29941643
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Institute of Cancer Research, United Kingdom
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: Jenni Parmar, RN Institute of Cancer Research, United Kingdom
PRS Account National Cancer Institute (NCI)
Verification Date June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP