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

UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer; Hot Flashes; Osteoporosis; Menopausal Symptoms
• Intervention / Treatment: Drug: conjugated estrogens; Biological: therapeutic progesterone

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: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Sutton, England, United Kingdom, SM2 5NG
      • Institute of Cancer Research - UK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized

Collaborators and Investigators

• Sponsor: Institute of Cancer Research, United Kingdom
• Investigators: Jenni Parmar, RN, Institute of Cancer Research, United Kingdom

Study record dates

Study Major Dates

• Study Start: March 1, 2002

Study Registration Dates

• First Submitted: March 8, 2004
• First Submitted That Met QC Criteria: March 9, 2004
• First Posted (Estimate): March 10, 2004

Study Record Updates

• Last Update Posted (Estimate): May 12, 2009
• Last Update Submitted That Met QC Criteria: May 9, 2009
• Last Verified: June 1, 2005

More Information

Terms related to this study

• Keywords: osteoporosis; stage II breast cancer; stage I breast cancer; menopausal symptoms; hot flashes
• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Breast Neoplasms; Osteoporosis; Hot Flashes; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone; Estrogens; Estrogens, Conjugated (USP)
• Other Study ID Numbers: CDR0000355122; CRUK-HRT; EU-20112; ISRCTN29941643