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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00079248
First Posted: March 10, 2004
Last Update Posted: May 12, 2009
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention
Breast Cancer Hot Flashes Menopausal Symptoms Osteoporosis Biological: therapeutic progesterone Drug: conjugated estrogens

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2002
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.

  Eligibility

Information from the National Library of Medicine

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

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)
  Contacts and Locations
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


Locations
United Kingdom
Institute of Cancer Research - UK
Sutton, England, United Kingdom, SM2 5NG
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
OverallOfficial: Jenni Parmar, RN Institute of Cancer Research, United Kingdom
  More Information

ClinicalTrials.gov Identifier: NCT00079248     History of Changes
Other Study ID Numbers: CDR0000355122
CRUK-HRT
EU-20112
ISRCTN29941643
First Submitted: March 8, 2004
First Posted: March 10, 2004
Last Update Posted: May 12, 2009
Last Verified: June 2005

Keywords provided by National Cancer Institute (NCI):
osteoporosis
stage I breast cancer
stage II breast cancer
menopausal symptoms
hot flashes

Additional relevant MeSH terms:
Breast Neoplasms
Osteoporosis
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Signs and Symptoms
Hormones
Progesterone
Estrogens, Conjugated (USP)
Estrogens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins