Breast CancerNCT00031850
Raloxifene and Goserelin in Preventing Breast Cancer in Women With a Family History of Breast Cancer
A study testing goserelin acetate and raloxifene in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of raloxifene and goserelin may be effective in preventing breast cancer. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- goserelin acetate and raloxifene
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2000to May 2007
- 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 30 to 45 years
- Women only
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- High genetic risk of developing breast cancer defined as one or more of the following:
- BRCA1 or BRCA2 germ-line mutation
- First-degree relative of known BRCA1 or BRCA2 mutation carrier
- Family with 4 or more relatives diagnosed with female or male breast cancer or ovarian cancer before the age of 60
- Two first-degree relatives diagnosed with breast cancer before the age of 40
- p53 germ-line mutation (classical Li-Fraumeni syndrome (LFS) only)
- First-degree relative of a carrier in a family with classical LFS
- Risk equivalent to any of the above confirmed by clinical geneticist
- No evidence of breast cancer by mammography
- Suspicious lesions must be confirmed as non-malignant
- No prior breast cancer
- No prior prophylactic mastectomy
- No plan for alternative prevention measures within the next 12 months
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 30 to 45
Sex:
- Female
Menopausal status:
- Premenopausal (follicle-stimulating hormone in premenopausal range if not menstruating)
Performance status:
- Not specified
Life expectancy:
- More than 10 years (excluding breast cancer risk)
Hematopoietic:
- Not specified
Hepatic:
- Adequate liver function
Renal:
- Adequate renal function
Cardiovascular:
- No prior deep vein thrombosis
Pulmonary:
- No prior pulmonary embolism
Other:
- Not pregnant
- Fertile patients must use effective nonhormonal contraception
- No psychological disorder that would preclude study compliance
- No prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or cervical cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent hormonal therapy (e.g., oral contraception or hormone replacement therapy)
Radiotherapy:
- Not specified
Surgery:
- See Disease Characteristics
Other:
- At least 30 days or 5 half-lives since prior investigational drugs
- No concurrent anticoagulants
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Christie Hospital NHS Trust
Manchester, England, M20 4BX
About this study
Official title: A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of raloxifene and goserelin may be effective in preventing breast cancer.
PURPOSE: Randomized pilot study to study the effectiveness of combining raloxifene and goserelin in preventing breast cancer in women who have a family history of breast cancer.
Read the detailed description
OBJECTIVES:
- Compare the feasibility of raloxifene and goserelin versus no medical intervention in women at high genetic risk for developing breast cancer.
- Compare the incidence of adverse effects in patients treated with these regimens.
- Compare the effect of these regimens on bone density, biochemical markers of bone turnover, and lipid profiles in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive goserelin subcutaneously once every month and oral raloxifene daily for 6-12 months.
- Arm II: Patients are screened for breast cancer every 6 months. In both arms, patients undergo annual mammograms.
Quality of life is assessed at baseline and at 1, 3, 6, and 12 months.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- goserelin acetate, raloxifene
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
goserelin acetateDrug
raloxifeneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2000
- Study completionMay 2007
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
- Prevention
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Investigators
- Anthony Howell, MD, Study chair, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031850
- Sponsor's protocol ID
- NCRI-IBIS-RAZOR
- Other IDs
- CDR0000069233, EU-20053, UKCCCR-IBIS-RAZOR, ISRCTN17775670
- Status last verified
- May 2007
- First submitted
- 8 Mar 2002
- Last updated
- 26 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Of Raloxifene Plus Zoladex For Prevention Of Breast Cancer
- ClinicalTrials.gov ID
- NCT00031850
- Acronym / sponsor ID
- NCRI-IBIS-RAZOR
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- Mar 2000
- Study completion
- May 2007 (actual)
- First posted
- 27 Jan 2003 (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: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of raloxifene and goserelin may be effective in preventing breast cancer.
PURPOSE: Randomized pilot study to study the effectiveness of combining raloxifene and goserelin in preventing breast cancer in women who have a family history of breast cancer.
Detailed description
OBJECTIVES:
- Compare the feasibility of raloxifene and goserelin versus no medical intervention in women at high genetic risk for developing breast cancer.
- Compare the incidence of adverse effects in patients treated with these regimens.
- Compare the effect of these regimens on bone density, biochemical markers of bone turnover, and lipid profiles in these patients.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive goserelin subcutaneously once every month and oral raloxifene daily for 6-12 months.
- Arm II: Patients are screened for breast cancer every 6 months. In both arms, patients undergo annual mammograms.
Quality of life is assessed at baseline and at 1, 3, 6, and 12 months.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 150 patients (75 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Prevention
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| goserelin acetate | Drug | – |
| raloxifene | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2013.
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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.
Anthony Howell, MD study chair
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing goserelin acetate and raloxifene in people with Breast Cancer, 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.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 26 Jun 2013; AzTrials last refreshed its copy on 8 Nov 2026.