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

Primary Purpose

Breast Cancer, Hot Flashes, Menopausal Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
therapeutic progesterone
conjugated estrogens
Sponsored by
Institute of Cancer Research, United Kingdom
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring osteoporosis, stage I breast cancer, stage II breast cancer, menopausal symptoms, hot flashes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Institute of Cancer Research - UK

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2004
Last Updated
May 9, 2009
Sponsor
Institute of Cancer Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT00079248
Brief Title
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

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institute of Cancer Research, United Kingdom

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Hot Flashes, Menopausal Symptoms, Osteoporosis
Keywords
osteoporosis, stage I breast cancer, stage II breast cancer, menopausal symptoms, hot flashes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
therapeutic progesterone
Intervention Type
Drug
Intervention Name(s)
conjugated estrogens

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenni Parmar, RN
Organizational Affiliation
Institute of Cancer Research, United Kingdom
Facility Information:
Facility Name
Institute of Cancer Research - UK
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5NG
Country
United Kingdom

12. IPD Sharing Statement

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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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