NCT00079248

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2004

Completed
Last Updated

May 12, 2009

Status Verified

June 1, 2005

First QC Date

March 8, 2004

Last Update Submit

May 9, 2009

Conditions

Breast CancerHot FlashesMenopausal SymptomsOsteoporosis

Keywords

osteoporosisstage I breast cancerstage II breast cancermenopausal symptomshot flashes

Interventions

therapeutic progesteroneBIOLOGICAL
conjugated estrogensDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (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

Study Sites (1)

Institute of Cancer Research - UK

Sutton, England, SM2 5NG, United Kingdom

Location

MeSH Terms

Conditions

Breast NeoplasmsHot FlashesOsteoporosis

Interventions

ProgesteroneEstrogens, Conjugated (USP)

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid HormonesEstradiol 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)