Breast CancerNCT00079248
Hormone Replacement Therapy in Relieving Menopausal Symptoms in Postmenopausal Women With Previous Stage I or Stage II Breast Cancer
A study testing therapeutic progesterone and conjugated estrogens in people with Breast Cancer and Hot Flashes, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Hot Flashes, Menopausal Symptoms
- What is being tested?
- therapeutic progesterone and conjugated estrogens
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2002to not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Institute of Cancer Research - UK
Sutton, England, SM2 5NG
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Hot Flashes, Menopausal Symptoms, Osteoporosis
- Being tested
- therapeutic progesterone, conjugated estrogens
- Keywords
- osteoporosis, stage I breast cancer, stage II breast cancer, menopausal symptoms, hot flashes
- Medical subject headings
- Breast Neoplasms, Hot Flashes, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic progesteroneBiological
conjugated estrogensDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2004 (estimated)
- Study startMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Investigators
- Jenni Parmar, RN, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079248
- Sponsor's protocol ID
- CDR0000355122
- Other IDs
- CRUK-HRT, EU-20112, ISRCTN29941643
- Status last verified
- Jun 2005
- First submitted
- 8 Mar 2004
- Last updated
- 12 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UK Trial Of Hormone Replacement Therapy (HRT) In Women With A History Of Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT00079248
- Acronym / sponsor ID
- CDR0000355122
- Conditions
- Breast Cancer, Hot Flashes, Menopausal Symptoms, Osteoporosis
- Keywords
- osteoporosis, stage I breast cancer, stage II breast cancer, menopausal symptoms, hot flashes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- Mar 2002
- First posted
- 10 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic progesterone | Biological | – |
| conjugated estrogens | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenni Parmar, RN
Institute of Cancer Research, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic progesterone and conjugated estrogens in people with Breast Cancer and Hot Flashes, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2009.