Breast CancerPhase 3NCT00002460
Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer
A Phase 3 study testing goserelin acetate, tamoxifen citrate and ablative endocrine surgery in people with Breast Cancer, run by Cancer Research UK at 34 sites in 2 countries.
Trial summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. PURPOSE: Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or ovarian ablation with goserelin or both in treating women with… Read more about this study
- Who is it for?
- Ages Up to 49 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- goserelin acetate, tamoxifen citrate and ablative endocrine surgery
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 34 sitesin 2 countries
- Study dates
- Sep 1987to not given
- Phase
- Phase 3
- 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 Up to 49 years
- Women only
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS: Operable, clinical Stage I/II breast cancer (T1-3, N0-1, M0) No evidence of distant metastases on x-ray of chest, spine, and pelvis Bone scan evidence alone of secondary mass allowed unless considered unequivocal evidence of metastasis No primary carcinoma fixed to underlying muscle or chest wall No deeply fixed axillary nodes No ulceration, skin infiltration, or peau d'orange involving more than 1/3 of breast No bilateral tumors Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: Under 50 Sex: Women only Menopausal status: Any status Performance status: Not specified Life expectancy: No limits on life expectancy due to intercurrent illness Hematopoietic: WBC at least 3,000 Platelets at least 90,000 Hemoglobin at least 10 g/dL Hepatic: Normal liver function required Renal: Normal kidney function required Other: Fit for surgery No prior treatment for other malignancies except: Nonmelanomatous skin cancer Cone-biopsied in situ carcinoma of the cervix English-speaking patients eligible for quality-of-life assessments
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Chemotherapy for high-risk patients allowed at the discretion of the clinician Endocrine therapy: At least 6 weeks since prior hormonal therapy No concomitant hormonal therapy including oral contraceptives (patients must discontinue the pill for 2 years) Radiotherapy: Not specified Surgery: Not specified
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United Kingdom31 sites
Belfast City Hospital Trust
Belfast, Northern Ireland, BT8 8JR
Belfast City Hospital Trust
Belfast, Northern Ireland, BT9 7AB
Royal Sussex County Hospital
Brighton, England, BN2 5BE
Velindre Hospital
Cardiff, Wales, CF4 7XL
Castle Hill Hospital
Cottingham, England, HU16 5JQ
Walsgrave Hospital
Coventry, England, CV2 2DX
Mayday University Hospital
Croydon, England
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA
Cookridge Hospital
Leeds, England, LS16 6QB
Whittington Hospital
London, England, N19 5NF
Guy's, King's and St. Thomas' Hospitals Trust
London, England, SE1 7EH
Cancer Research Campaign Clinical Trials Unit-London
London, England, SE5 9NU
Royal Marsden NHS Trust
London, England, SW3 6JJ
Middlesex Hospital- Meyerstein Institute
London, England, W1N 8AA
Mid-Ulster Hospital
Londonderry, Northern Ireland, BT45 5EX
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, L63 4JY
South Tees Acute Hospitals NHS Trust
Middlesbrough, Cleveland, England, TS4 3BW
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Ards General Hospital
Newtownards, Northern Ireland
Derriford Hospital
Plymouth, England, PL6 8DH
Portsmouth Hospitals NHS Trust
Portsmouth, England, P03 6AD
Salisbury General Infirmary
Salisbury, England, SP2 7SX
Royal South Hants Hospital
Southampton, England, SO14 0YG
Southampton General Hospital
Southampton, England, SO16 6YD
North Tees General Hospital
Stockton-on-Tees, England, TS19 8PE
North Staffs Royal Infirmary
Stoke-on-Trent, England, ST4 7LN
Radiotherapy Department
Stratford-on-Avon, Warwickshire, England, CV37 6NX
Sunderland Royal Infirmary
Sunderland, England, SR2 7JE
Royal Marsden Hospital
Sutton, England, SM2 5PT
Royal Hampshire County Hospital
Winchester, England, SO22 5DG
Belgium3 sites
Hopital De Braine-L'Alleud-Waterloo
Braine-l'Alleud, 1420
Institut Jules Bordet
Brussels, 1000
U.Z. Sint-Rafael
Leuven, B-3000
About this study
Official title: Phase III Randomized Study of Adjuvant Therapy With Tamoxifen vs Endocrine Ablation vs Tamoxifen Plus Endocrine Ablation vs No Adjuvant Therapy in Patients Under Age 50 With Operable Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen.
PURPOSE: Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or ovarian ablation with goserelin or both in treating women with stage I or stage II breast cancer.
Read the detailed description
OBJECTIVES: I. Determine, in a prospective, randomized, controlled trial whether the administration of a course of adjuvant tamoxifen or ablation of ovarian function results in prolongation of time to recurrence or death in patients under 50 years of age with operable carcinoma of the breast. II. Determine how hormone manipulation affects mood and sexual functioning in these patients.
OUTLINE: This is a randomized study. Patients are stratified by clinician. All patients are randomized following primary therapy, which, in addition to surgery, may include local irradiation, perioperative cyclophosphamide, or up to 6 cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF) for high-risk patients. Clinicians may elect to randomize patients to all groups or to only those groups including tamoxifen. The first group receives no further therapy. Then second group receives tamoxifen daily for at least 2 years. The third group receives ovarian ablation with goserelin via monthly injection for at least 2 years. The final group receives ovarian ablation with goserelin plus daily tamoxifen for at least 2 years. All patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually.
PROJECTED ACCRUAL: 800 to 1,000 patients will be entered.
- Conditions
- Breast Cancer
- Being tested
- goserelin acetate, tamoxifen citrate, ablative endocrine surgery, oophorectomy
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA 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
tamoxifen citrateDrug
ablative endocrine surgeryProcedure or surgery
oophorectomyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2004 (estimated)
- Study startSep 1987
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.
- 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 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Cancer Research UK
- Sponsor type
- University, hospital or other
- Investigators
- Michael Baum, MD, ChM, FRCS, Study chair, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002460
- Sponsor's protocol ID
- CRC-PHASE-III-88002
- Other IDs
- CDR0000075539, UKM-CRC-BR-UNDER 50
- Status last verified
- Dec 2006
- First submitted
- 1 Nov 1999
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Study of Adjuvant Therapy With Tamoxifen vs Endocrine Ablation vs Tamoxifen Plus Endocrine Ablation vs No Adjuvant Therapy in Patients Under Age 50 With Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT00002460
- Acronym / sponsor ID
- CRC-PHASE-III-88002
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Cancer Research UKUniversity, hospital or other
- Study start
- Sep 1987
- First posted
- 9 Jun 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: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen.
PURPOSE: Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or ovarian ablation with goserelin or both in treating women with stage I or stage II breast cancer.
Detailed description
OBJECTIVES: I. Determine, in a prospective, randomized, controlled trial whether the administration of a course of adjuvant tamoxifen or ablation of ovarian function results in prolongation of time to recurrence or death in patients under 50 years of age with operable carcinoma of the breast. II. Determine how hormone manipulation affects mood and sexual functioning in these patients.
OUTLINE: This is a randomized study. Patients are stratified by clinician. All patients are randomized following primary therapy, which, in addition to surgery, may include local irradiation, perioperative cyclophosphamide, or up to 6 cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF) for high-risk patients. Clinicians may elect to randomize patients to all groups or to only those groups including tamoxifen. The first group receives no further therapy. Then second group receives tamoxifen daily for at least 2 years. The third group receives ovarian ablation with goserelin via monthly injection for at least 2 years. The final group receives ovarian ablation with goserelin plus daily tamoxifen for at least 2 years. All patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually.
PROJECTED ACCRUAL: 800 to 1,000 patients will be entered.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- Up to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 | – |
| tamoxifen citrate | Drug | – |
| ablative endocrine surgery | Procedure or surgery | – |
| oophorectomy | Procedure or surgery | – |
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 7 Aug 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.
Michael Baum, MD, ChM, FRCS study chair
University College London Hospitals
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing goserelin acetate, tamoxifen citrate and ablative endocrine surgery in people with Breast Cancer, run by Cancer Research UK at 34 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United Kingdom, Belgium. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 7 Aug 2013.