Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer
- Conditions
- InfertilityMenopausal SymptomsBreast Cancer
- Registration Number
- NCT00427245
- Lead Sponsor
- Anglo Celtic Cooperative Oncology Group
- Brief 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.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months
- Secondary Outcome Measures
Name Time Method 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 Incidence of pregnancy 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
Trial Locations
- Locations (66)
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Saint Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Portsmouth Oncology Centre at Saint Mary's Hospital
🇬🇧Portsmouth Hants, England, United Kingdom
Queen Margaret Hospital - Dunfermline
🇬🇧Dunfermline, Scotland, United Kingdom
North Manchester General Hospital - Penine Actute Hospitals Trust
🇬🇧Manchester, England, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, England, United Kingdom
King George Hospital
🇬🇧Ilford, Essex, England, United Kingdom
Frenchay Hospital
🇬🇧Bristol, England, United Kingdom
Whittington Hospital
🇬🇧London, England, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Southern General Hospital
🇬🇧Glasgow, Scotland, United Kingdom
Falkirk and District Royal Infirmary
🇬🇧Falkirk, Scotland, United Kingdom
Luton and Dunstable Hospital
🇬🇧Luton-Bedfordshire, England, United Kingdom
Halton Hospital
🇬🇧Cheshire, England, United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
🇬🇧Basingstoke, England, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Helen Rollason Cancer Care Centre at North Middlesex Hospital
🇬🇧London, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, England, United Kingdom
St. George's Hospital
🇬🇧London, England, United Kingdom
Royal Alexandra Hospital
🇬🇧Paisley, Scotland, United Kingdom
Oldchurch Hospital
🇬🇧Romford, England, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
Royal Infirmary - Castle
🇬🇧Glasgow, Scotland, United Kingdom
Bronglais District General Hospital
🇬🇧Aberystwyth, Wales, United Kingdom
Royal Glamorgan Hospital
🇬🇧Lhantrisant, Wales, United Kingdom
Velindre Cancer Center at Velindre Hospital
🇬🇧Cardiff, Wales, United Kingdom
Royal United Hospital
🇬🇧Bath, England, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, England, United Kingdom
Essex County Hospital
🇬🇧Colchester, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧Gateshead, England, United Kingdom
UCL Cancer Institute
🇬🇧Hampstead, London, England, United Kingdom
Diana Princess of Wales Hospital
🇬🇧Grimsby, England, United Kingdom
Huddersfield Royal Infirmary
🇬🇧Huddersfield, West Yorks, England, United Kingdom
Kidderminster Hospital
🇬🇧Kidderminster Worcestershire, England, United Kingdom
Yorkshire Regional Clinical Trials & Research Unit
🇬🇧Leeds, England, United Kingdom
Newham University Hospital
🇬🇧London, England, United Kingdom
Whipps Cross Hospital
🇬🇧London, England, United Kingdom
Homerton University Hospital
🇬🇧London, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Peterborough Hospitals Trust
🇬🇧Peterborough, England, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, England, United Kingdom
Kent and Sussex Hospital
🇬🇧Tunbridge Wells, Kent, England, United Kingdom
Warrington Hospital NHS Trust
🇬🇧Warrington, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, England, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil - Somerset, England, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Dumfries & Galloway Royal Infirmary
🇬🇧Dumfries, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Raigmore Hospital
🇬🇧Inverness, Scotland, United Kingdom
Crosshouse Hospital
🇬🇧Kilmarnock, Scotland, United Kingdom
Glan Clwyd Hospital
🇬🇧Rhyl, Denbighshire, Wales, United Kingdom
Withybush General Hospital
🇬🇧Haverfordwest, Wales, United Kingdom
South West Wales Cancer Institute
🇬🇧Swansea, Wales, United Kingdom
Scunthorpe General Hospital
🇬🇧Scunthorpe, England, United Kingdom
Dorset Cancer Centre
🇬🇧Poole Dorset, England, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, Wales, United Kingdom
Guy's Hospital
🇬🇧London, England, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, England, United Kingdom