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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00427245
First received: January 25, 2007
Last updated: August 6, 2013
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Infertility
Menopausal Symptoms
Drug: cyclophosphamide
Drug: goserelin acetate
Procedure: adjuvant therapy
Procedure: fertility assessment and management
Procedure: neoadjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 400
Study Start Date: August 2004
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427245

  Hide Study Locations
Locations
United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
Royal United Hospital
Bath, England, United Kingdom, BA1 3NG
Frenchay Hospital
Bristol, England, United Kingdom, BS16 1LE
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Halton Hospital
Cheshire, England, United Kingdom, WA7 2DA
Essex County Hospital
Colchester, England, United Kingdom, C03 3NB
Dorset County Hospital
Dorchester, England, United Kingdom, DT1 2JY
Russells Hall Hospital
Dudley, England, United Kingdom, DY1 2HQ
Queen Elizabeth Hospital
Gateshead, England, United Kingdom, NE9 6SX
Diana Princess of Wales Hospital
Grimsby, England, United Kingdom, DN33 2BA
UCL Cancer Institute
Hampstead, London, England, United Kingdom, NW3 2QG
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
King George Hospital
Ilford, Essex, England, United Kingdom, IG3 8YB
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
Kidderminster Hospital
Kidderminster Worcestershire, England, United Kingdom, DY11 6RJ
Yorkshire Regional Clinical Trials & Research Unit
Leeds, England, United Kingdom, LS16 6QB
Royal Liverpool University Hospital
Liverpool, England, United Kingdom, L7 8XP
Guy's Hospital
London, England, United Kingdom, SE1 9RT
Charing Cross Hospital
London, England, United Kingdom, W6 8RF
Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, England, United Kingdom, N18 1QX
Homerton University Hospital
London, England, United Kingdom, E9 6SR
Newham University Hospital
London, England, United Kingdom, E13 85L
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
St. George's Hospital
London, England, United Kingdom, SW17 0QT
Whittington Hospital
London, England, United Kingdom, N19 5NF
Whipps Cross Hospital
London, England, United Kingdom, E11 1NR
Luton and Dunstable Hospital
Luton-Bedfordshire, England, United Kingdom, LU4 0DZ
Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
North Manchester General Hospital - Penine Actute Hospitals Trust
Manchester, England, United Kingdom, M8 6RB
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom, NR4 7UY
Peterborough Hospitals Trust
Peterborough, England, United Kingdom, PE3 6DA
Dorset Cancer Centre
Poole Dorset, England, United Kingdom, BH15 2JB
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, United Kingdom, PO3 6AD
Oldchurch Hospital
Romford, England, United Kingdom, RM7 OBE
Salisbury District Hospital
Salisbury, England, United Kingdom, SP2 8BJ
Scunthorpe General Hospital
Scunthorpe, England, United Kingdom, DN15 7BH
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom, TR1 3LJ
Kent and Sussex Hospital
Tunbridge Wells, Kent, England, United Kingdom, TN4 8AT
Warrington Hospital NHS Trust
Warrington, England, United Kingdom, WA5 1QG
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
New Cross Hospital
Wolverhampton, England, United Kingdom, WV10 0QP
Yeovil District Hospital
Yeovil - Somerset, England, United Kingdom, BA21 4AT
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Dumfries & Galloway Royal Infirmary
Dumfries, Scotland, United Kingdom, DG1 4AP
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Queen Margaret Hospital - Dunfermline
Dunfermline, Scotland, United Kingdom, KY12 0SU
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Falkirk and District Royal Infirmary
Falkirk, Scotland, United Kingdom, FK1 5QE
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Southern General Hospital
Glasgow, Scotland, United Kingdom, G51 4TF
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom, G4 0SF
Raigmore Hospital
Inverness, Scotland, United Kingdom, 1V2 3UJ
Crosshouse Hospital
Kilmarnock, Scotland, United Kingdom, KA2 OBE
Royal Alexandra Hospital
Paisley, Scotland, United Kingdom
Bronglais District General Hospital
Aberystwyth, Wales, United Kingdom, SY23 1ER
Ysbyty Gwynedd
Bangor, Wales, United Kingdom, LL57 2PW
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
Withybush General Hospital
Haverfordwest, Wales, United Kingdom, SA61 2PZ
Royal Glamorgan Hospital
Lhantrisant, Wales, United Kingdom, CF72 8XR
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
South West Wales Cancer Institute
Swansea, Wales, United Kingdom, SA2 8QA
Sponsors and Collaborators
Anglo Celtic Cooperative Oncology Group
Investigators
Study Chair: Robert C.F. Leonard, MD, BS, MB Charing Cross Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00427245     History of Changes
Other Study ID Numbers: CRUK-OPTION, CDR0000526368, EUDRACT-2004-000133-11, CRUK-BR0402, ISRCTN84856516, EU-20680
Study First Received: January 25, 2007
Last Updated: August 6, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Breast Neoplasms
Infertility
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Genital Diseases, Male
Genital Diseases, Female
Cyclophosphamide
Goserelin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on August 19, 2014