Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer

NCT00427245 | Completed Phase 3

• 6 other identifiers: CRUK-OPTIONCDR0000526368EUDRACT-2004-000133-11CRUK-BR0402ISRCTN84856516EU-20680
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 66

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.

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; estrogen receptor-positive breast cancer; progesterone receptor-negative breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

cyclophosphamide DRUG

goserelin acetate DRUG

adjuvant therapy PROCEDURE

fertility assessment and management PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Anglo Celtic Cooperative Oncology Group: lead

Study Sites (66)

Basingstoke and North Hampshire NHS Foundation Trust

Basingstoke, England, RG24 9NA, United Kingdom

Location

Royal United Hospital

Bath, England, BA1 3NG, United Kingdom

Location

Frenchay Hospital

Bristol, England, BS16 1LE, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, England, CB2 2QQ, United Kingdom

Location

Halton Hospital

Cheshire, England, WA7 2DA, United Kingdom

Location

Essex County Hospital

Colchester, England, C03 3NB, United Kingdom

Location

Dorset County Hospital

Dorchester, England, DT1 2JY, United Kingdom

Location

Russells Hall Hospital

Dudley, England, DY1 2HQ, United Kingdom

Location

Queen Elizabeth Hospital

Gateshead, England, NE9 6SX, United Kingdom

Location

Diana Princess of Wales Hospital

Grimsby, England, DN33 2BA, United Kingdom

Location

UCL Cancer Institute

Hampstead, London, England, NW3 2QG, United Kingdom

Location

Huddersfield Royal Infirmary

Huddersfield, West Yorks, England, HD3 3EA, United Kingdom

Location

King George Hospital

Ilford, Essex, England, IG3 8YB, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Kidderminster Hospital

Kidderminster Worcestershire, England, DY11 6RJ, United Kingdom

Location

Yorkshire Regional Clinical Trials & Research Unit

Leeds, England, LS16 6QB, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L7 8XP, United Kingdom

Location

Whipps Cross Hospital

London, England, E11 1NR, United Kingdom

Location

Newham University Hospital

London, England, E13 85L, United Kingdom

Location

Homerton University Hospital

London, England, E9 6SR, United Kingdom

Location

Saint Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Helen Rollason Cancer Care Centre at North Middlesex Hospital

London, England, N18 1QX, United Kingdom

Location

Whittington Hospital

London, England, N19 5NF, United Kingdom

Location

Guy's Hospital

London, England, SE1 9RT, United Kingdom

Location

St. George's Hospital

London, England, SW17 0QT, United Kingdom

Location

Charing Cross Hospital

London, England, W6 8RF, United Kingdom

Location

Luton and Dunstable Hospital

Luton-Bedfordshire, England, LU4 0DZ, United Kingdom

Location

Maidstone Hospital

Maidstone, England, ME16 9QQ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

North Manchester General Hospital - Penine Actute Hospitals Trust

Manchester, England, M8 6RB, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, HA6 2RN, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, England, NR4 7UY, United Kingdom

Location

Peterborough Hospitals Trust

Peterborough, England, PE3 6DA, United Kingdom

Location

Dorset Cancer Centre

Poole Dorset, England, BH15 2JB, United Kingdom

Location

Portsmouth Oncology Centre at Saint Mary's Hospital

Portsmouth Hants, England, PO3 6AD, United Kingdom

Location

Oldchurch Hospital

Romford, England, RM7 OBE, United Kingdom

Location

Salisbury District Hospital

Salisbury, England, SP2 8BJ, United Kingdom

Location

Scunthorpe General Hospital

Scunthorpe, England, DN15 7BH, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Cornwall Hospital

Truro, Cornwall, England, TR1 3LJ, United Kingdom

Location

Kent and Sussex Hospital

Tunbridge Wells, Kent, England, TN4 8AT, United Kingdom

Location

Warrington Hospital NHS Trust

Warrington, England, WA5 1QG, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

New Cross Hospital

Wolverhampton, England, WV10 0QP, United Kingdom

Location

Yeovil District Hospital

Yeovil - Somerset, England, BA21 4AT, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Dumfries & Galloway Royal Infirmary

Dumfries, Scotland, DG1 4AP, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Queen Margaret Hospital - Dunfermline

Dunfermline, Scotland, KY12 0SU, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Falkirk and District Royal Infirmary

Falkirk, Scotland, FK1 5QE, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Royal Infirmary - Castle

Glasgow, Scotland, G4 0SF, United Kingdom

Location

Southern General Hospital

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Raigmore Hospital

Inverness, Scotland, 1V2 3UJ, United Kingdom

Location

Crosshouse Hospital

Kilmarnock, Scotland, KA2 OBE, United Kingdom

Location

Royal Alexandra Hospital

Paisley, Scotland, United Kingdom

Location

Bronglais District General Hospital

Aberystwyth, Wales, SY23 1ER, United Kingdom

Location

Ysbyty Gwynedd

Bangor, Wales, LL57 2PW, United Kingdom

Location

Velindre Cancer Center at Velindre Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

Withybush General Hospital

Haverfordwest, Wales, SA61 2PZ, United Kingdom

Location

Royal Glamorgan Hospital

Lhantrisant, Wales, CF72 8XR, United Kingdom

Location

Glan Clwyd Hospital

Rhyl, Denbighshire, Wales, LL 18 5UJ, United Kingdom

Location

South West Wales Cancer Institute

Swansea, Wales, SA2 8QA, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Infertility

Interventions

Cyclophosphamide; Goserelin; Chemotherapy, Adjuvant; Therapeutics; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Combined Modality Therapy; Drug Therapy

Study Officials

• Robert C.F. Leonard, MD, BS, MB

  Charing Cross Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: January 29, 2007
• Study Start: August 1, 2004
• Last Updated: August 7, 2013

Record last verified: 2007-05

Locations

GB (66)