Breast CancerPhase 3NCT00427245
Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer
A Phase 3 study testing cyclophosphamide, goserelin acetate and adjuvant therapy in people with Breast Cancer and Infertility, run by Anglo Celtic Cooperative Oncology Group at 66 sites in United Kingdom.
Trial summary
RATIONALE: Goserelin may help prevent early menopause in patients undergoing chemotherapy for breast cancer. It is not yet known whether goserelin is effective in preventing early menopause in women undergoing chemotherapy for breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Infertility, Menopausal Symptoms
- What is being tested?
- cyclophosphamide, goserelin acetate and adjuvant therapy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 66 sitesUnited Kingdom
- Study dates
- Aug 2004to 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Stages I-IIIB with node-positive or -negative disease (N0-2)
- Operable disease
- Must meet 1 of the following criteria:
- Has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past 8 weeks
- Scheduled to receive neoadjuvant chemotherapy
- No metastatic breast cancer, including supraclavicular fossa metastases
- Hormone receptor status meeting 1 of the following criteria:
- Estrogen receptor (ER) and progesterone receptor poor or negative AND not a candidate for adjuvant endocrine therapy
- ER positive AND no requirement for ovarian suppression as a necessary part of treatment
PATIENT CHARACTERISTICS:
- Female
- Premenopausal with regular menses in the 12 months preceding surgery
- No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Suitable fitness status for chemotherapy
- Adequate hepatic, renal, and bone marrow function
- Not pregnant or nursing
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or endocrine therapy
Trial locations and contacts
66 sites in 1 country.
66 sites in 1 country
United Kingdom66 sites
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Bronglais District General Hospital
Aberystwyth, Wales, SY23 1ER
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, RG24 9NA
Royal United Hospital
Bath, England, BA1 3NG
Frenchay Hospital
Bristol, England, BS16 1LE
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Halton Hospital
Cheshire, England, WA7 2DA
Essex County Hospital
Colchester, England, C03 3NB
Dorset County Hospital
Dorchester, England, DT1 2JY
Russells Hall Hospital
Dudley, England, DY1 2HQ
Dumfries & Galloway Royal Infirmary
Dumfries, Scotland, DG1 4AP
Ninewells Hospital
Dundee, Scotland, DD1 9SY
Queen Margaret Hospital - Dunfermline
Dunfermline, Scotland, KY12 0SU
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU
Falkirk and District Royal Infirmary
Falkirk, Scotland, FK1 5QE
Queen Elizabeth Hospital
Gateshead, England, NE9 6SX
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G11 6NT
Royal Infirmary - Castle
Glasgow, Scotland, G4 0SF
Southern General Hospital
Glasgow, Scotland, G51 4TF
Diana Princess of Wales Hospital
Grimsby, England, DN33 2BA
UCL Cancer Institute
Hampstead, London, England, NW3 2QG
Withybush General Hospital
Haverfordwest, Wales, SA61 2PZ
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, HD3 3EA
King George Hospital
Ilford, Essex, England, IG3 8YB
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ
Ipswich Hospital
Ipswich, England, IP4 5PD
Kidderminster Hospital
Kidderminster Worcestershire, England, DY11 6RJ
Crosshouse Hospital
Kilmarnock, Scotland, KA2 OBE
Yorkshire Regional Clinical Trials & Research Unit
Leeds, England, LS16 6QB
Royal Glamorgan Hospital
Lhantrisant, Wales, CF72 8XR
Royal Liverpool University Hospital
Liverpool, England, L7 8XP
Whipps Cross Hospital
London, England, E11 1NR
Newham University Hospital
London, England, E13 85L
Homerton University Hospital
London, England, E9 6SR
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, England, N18 1QX
Whittington Hospital
London, England, N19 5NF
Guy's Hospital
London, England, SE1 9RT
St. George's Hospital
London, England, SW17 0QT
Charing Cross Hospital
London, England, W6 8RF
Luton and Dunstable Hospital
Luton-Bedfordshire, England, LU4 0DZ
Maidstone Hospital
Maidstone, England, ME16 9QQ
Christie Hospital
Manchester, England, M20 4BX
North Manchester General Hospital - Penine Actute Hospitals Trust
Manchester, England, M8 6RB
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Norfolk and Norwich University Hospital
Norwich, England, NR4 7UY
Royal Alexandra Hospital
Paisley, Scotland
Peterborough Hospitals Trust
Peterborough, England, PE3 6DA
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, PO3 6AD
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ
Oldchurch Hospital
Romford, England, RM7 OBE
Salisbury District Hospital
Salisbury, England, SP2 8BJ
Scunthorpe General Hospital
Scunthorpe, England, DN15 7BH
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Southampton General Hospital
Southampton, England, SO16 6YD
South West Wales Cancer Institute
Swansea, Wales, SA2 8QA
Royal Cornwall Hospital
Truro, Cornwall, England, TR1 3LJ
Kent and Sussex Hospital
Tunbridge Wells, Kent, England, TN4 8AT
Warrington Hospital NHS Trust
Warrington, England, WA5 1QG
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
New Cross Hospital
Wolverhampton, England, WV10 0QP
Yeovil District Hospital
Yeovil - Somerset, England, BA21 4AT
About this study
Official title: Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]
RATIONALE: Goserelin may help prevent early menopause in patients undergoing chemotherapy for breast cancer. It is not yet known whether goserelin is effective in preventing early menopause in women undergoing chemotherapy for breast cancer.
PURPOSE: This randomized phase III trial is studying goserelin to see how well it works compared with no goserelin in preventing early menopause in premenopausal women undergoing chemotherapy for stage I, stage II, or stage III breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Compare the incidence of premature ovarian failure after chemotherapy in premenopausal women with stage I-III breast cancer treated with goserelin vs no goserelin .
Secondary
- Compare the quality of life of patients treated with these regimens.
- Compare menopausal symptoms in patients treated with these regimens.
- Compare bone mineral density loss in patients treated with these regimens.
- Compare hormone levels in patients treated with these regimens.
- Compare menstruation in patients treated with these regimens.
- Compare the incidence of pregnancy in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, prospective, parallel group, multicenter study. Patients are stratified according to age (≤ 40 years vs > 40 years) and participating center. Patients are randomized to 1 of 2 treatment arms.
Arm I (chemotherapy alone): Patients receive neoadjuvant or adjuvant cyclophosphamide- and/or anthracycline-containing chemotherapy. Treatment continues for 6-8 courses in the absence of disease progression or unacceptable toxicity.
Arm II (chemotherapy plus goserelin for ovarian function suppression): Patients receive neoadjuvant or adjuvant chemotherapy as in arm I. Patients also receive goserelin subcutaneously every 3-4 weeks beginning 1-3 weeks before the start of chemotherapy. Treatment with goserelin repeats every 3-4 weeks until completion of chemotherapy.
Quality of life is assessed at baseline, at 3, 6, 12, 18, and 24 months, and then annually for up to 5 years.
After completion of study therapy, patients are followed periodically for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
- Conditions
- Breast Cancer, Infertility, Menopausal Symptoms
- Being tested
- cyclophosphamide, goserelin acetate, adjuvant therapy, fertility assessment and management, neoadjuvant therapy
- Keywords
- menopausal symptoms, infertility, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-negative breast cancer
- Medical subject headings
- Breast Neoplasms, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
goserelin acetateDrug
adjuvant therapyProcedure or surgery
fertility assessment and managementProcedure or surgery
neoadjuvant therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months
Secondary outcomes (6)
Incidence of menopausal symptoms
Quality of life
Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers
Hormone levels (including follicle-stimulating hormone, luteinizing hormone, beta-inhibin, and estradiol) as measured after course 3, after course 6 or 8 (depending on chemotherapy regimen), at 9 and 12 months, and then annually for up to 5 years
Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy
Incidence of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startAug 2004
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
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anglo Celtic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Investigators
- Robert C.F. Leonard, MD, BS, MB, Study chair, Charing Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427245
- Sponsor's protocol ID
- CRUK-OPTION
- Other IDs
- CDR0000526368, EUDRACT-2004-000133-11, CRUK-BR0402, ISRCTN84856516, EU-20680
- Status last verified
- May 2007
- First submitted
- 25 Jan 2007
- 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
- Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]
- ClinicalTrials.gov ID
- NCT00427245
- Acronym / sponsor ID
- CRUK-OPTION
- Conditions
- Breast Cancer, Infertility, Menopausal Symptoms
- Keywords
- menopausal symptoms, infertility, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, estrogen receptor-negative breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Anglo Celtic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Aug 2004
- First posted
- 29 Jan 2007 (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: Goserelin may help prevent early menopause in patients undergoing chemotherapy for breast cancer. It is not yet known whether goserelin is effective in preventing early menopause in women undergoing chemotherapy for breast cancer.
PURPOSE: This randomized phase III trial is studying goserelin to see how well it works compared with no goserelin in preventing early menopause in premenopausal women undergoing chemotherapy for stage I, stage II, or stage III breast cancer.
Detailed description
OBJECTIVES:
Primary
- Compare the incidence of premature ovarian failure after chemotherapy in premenopausal women with stage I-III breast cancer treated with goserelin vs no goserelin .
Secondary
- Compare the quality of life of patients treated with these regimens.
- Compare menopausal symptoms in patients treated with these regimens.
- Compare bone mineral density loss in patients treated with these regimens.
- Compare hormone levels in patients treated with these regimens.
- Compare menstruation in patients treated with these regimens.
- Compare the incidence of pregnancy in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, prospective, parallel group, multicenter study. Patients are stratified according to age (≤ 40 years vs > 40 years) and participating center. Patients are randomized to 1 of 2 treatment arms.
Arm I (chemotherapy alone): Patients receive neoadjuvant or adjuvant cyclophosphamide- and/or anthracycline-containing chemotherapy. Treatment continues for 6-8 courses in the absence of disease progression or unacceptable toxicity.
Arm II (chemotherapy plus goserelin for ovarian function suppression): Patients receive neoadjuvant or adjuvant chemotherapy as in arm I. Patients also receive goserelin subcutaneously every 3-4 weeks beginning 1-3 weeks before the start of chemotherapy. Treatment with goserelin repeats every 3-4 weeks until completion of chemotherapy.
Quality of life is assessed at baseline, at 3, 6, 12, 18, and 24 months, and then annually for up to 5 years.
After completion of study therapy, patients are followed periodically for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Masking
- None (open label)
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 |
|---|---|---|
| cyclophosphamide | Drug | – |
| goserelin acetate | Drug | – |
| adjuvant therapy | Procedure or surgery | – |
| fertility assessment and management | Procedure or surgery | – |
| neoadjuvant therapy | Procedure or surgery | – |
Primary outcome
Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months
6 secondary outcomes
Incidence of menopausal symptoms
Quality of life
Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers
Hormone levels (including follicle-stimulating hormone, luteinizing hormone, beta-inhibin, and estradiol) as measured after course 3, after course 6 or 8 (depending on chemotherapy regimen), at 9 and 12 months, and then annually for up to 5 years
Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy
Incidence of pregnancy
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 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.
Robert C.F. Leonard, MD, BS, MB study chair
Charing Cross Hospital
66 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cyclophosphamide, goserelin acetate and adjuvant therapy in people with Breast Cancer and Infertility, run by Anglo Celtic Cooperative Oncology Group at 66 sites 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: finished, 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 66 sites 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.
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?
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.
What does the primary outcome measure?
Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months. It is what the study was designed to measure, not a finding.
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.