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

August 6, 2013 updated by: Anglo Celtic Cooperative Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Quality of life
Incidence of menopausal symptoms
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anglo Celtic Cooperative Oncology Group

Investigators

  • Study Chair: Robert C.F. Leonard, MD, BS, MB, Charing Cross Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Registration Dates

First Submitted

January 25, 2007

First Submitted That Met QC Criteria

January 25, 2007

First Posted (Estimate)

January 29, 2007

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRUK-OPTION
  • CDR0000526368 (Registry Identifier: PDQ (Physician Data Query))
  • EUDRACT-2004-000133-11
  • CRUK-BR0402
  • ISRCTN84856516
  • EU-20680

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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