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

NCT00079248 | Unknown

• 4 other identifiers: CDR0000355122CRUK-HRTEU-20112ISRCTN29941643
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Hot Flashes; Menopausal Symptoms; Osteoporosis

Keywords

osteoporosis; stage I breast cancer; stage II breast cancer; menopausal symptoms; hot flashes

Interventions

therapeutic progesterone BIOLOGICAL

conjugated estrogens DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (1)

Institute of Cancer Research - UK

Sutton, England, SM2 5NG, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Hot Flashes; Osteoporosis

Interventions

Progesterone; Estrogens, Conjugated (USP)

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Estradiol Congeners

Study Officials

• Jenni Parmar, RN

  Institute of Cancer Research, United Kingdom

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 10, 2004
• Study Start: March 1, 2002
• Last Updated: May 12, 2009

Record last verified: 2005-06

Locations

GB (1)