Clinical trial NCT00079248: Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer
Official title: UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Hot Flashes
Menopausal Symptoms
Osteoporosis
Keywords: osteoporosis
stage I breast cancer
stage II breast cancer
menopausal symptoms
hot flashes
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-03-10
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Institute of Cancer Research - UK
state: England
Study officials:
affiliation: Institute of Cancer Research, United Kingdom
name: Jenni Parmar, RN
References: