Back to resultsGoserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer
Primary Purpose
Breast Cancer, Infertility, Menopausal Symptoms
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
cyclophosphamide
goserelin acetate
adjuvant therapy
fertility assessment and management
neoadjuvant therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring 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
Eligibility 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
Sites / Locations
- Basingstoke and North Hampshire NHS Foundation Trust
- Royal United Hospital
- Frenchay Hospital
- Addenbrooke's Hospital
- Halton Hospital
- Essex County Hospital
- Dorset County Hospital
- Russells Hall Hospital
- Queen Elizabeth Hospital
- Diana Princess of Wales Hospital
- UCL Cancer Institute
- Huddersfield Royal Infirmary
- King George Hospital
- Ipswich Hospital
- Kidderminster Hospital
- Yorkshire Regional Clinical Trials & Research Unit
- Royal Liverpool University Hospital
- Whipps Cross Hospital
- Newham University Hospital
- Homerton University Hospital
- Saint Bartholomew's Hospital
- Helen Rollason Cancer Care Centre at North Middlesex Hospital
- Whittington Hospital
- Guy's Hospital
- St. George's Hospital
- Charing Cross Hospital
- Luton and Dunstable Hospital
- Maidstone Hospital
- Christie Hospital
- North Manchester General Hospital - Penine Actute Hospitals Trust
- Clatterbridge Centre for Oncology
- Mount Vernon Cancer Centre at Mount Vernon Hospital
- Norfolk and Norwich University Hospital
- Peterborough Hospitals Trust
- Dorset Cancer Centre
- Portsmouth Oncology Centre at Saint Mary's Hospital
- Oldchurch Hospital
- Salisbury District Hospital
- Scunthorpe General Hospital
- Cancer Research Centre at Weston Park Hospital
- Southampton General Hospital
- Royal Cornwall Hospital
- Kent and Sussex Hospital
- Warrington Hospital NHS Trust
- Southend University Hospital NHS Foundation Trust
- New Cross Hospital
- Yeovil District Hospital
- Aberdeen Royal Infirmary
- Dumfries & Galloway Royal Infirmary
- Ninewells Hospital
- Queen Margaret Hospital - Dunfermline
- Edinburgh Cancer Centre at Western General Hospital
- Falkirk and District Royal Infirmary
- Beatson West of Scotland Cancer Centre
- Royal Infirmary - Castle
- Southern General Hospital
- Raigmore Hospital
- Crosshouse Hospital
- Royal Alexandra Hospital
- Bronglais District General Hospital
- Ysbyty Gwynedd
- Velindre Cancer Center at Velindre Hospital
- Withybush General Hospital
- Royal Glamorgan Hospital
- Glan Clwyd Hospital
- South West Wales Cancer Institute
Outcomes
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
Full Information
NCT ID
NCT00427245
First Posted
January 25, 2007
Last Updated
August 6, 2013
Sponsor
Anglo Celtic Cooperative Oncology Group
1. Study Identification
Unique Protocol Identification Number
NCT00427245
Brief Title
Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer
Official Title
Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Anglo Celtic Cooperative Oncology Group
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
goserelin acetate
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
fertility assessment and management
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Primary Outcome Measure Information:
Title
Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months
Secondary Outcome Measure Information:
Title
Incidence of menopausal symptoms
Title
Quality of life
Title
Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers
Title
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
Title
Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy
Title
Incidence of pregnancy
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert C.F. Leonard, MD, BS, MB
Organizational Affiliation
Charing Cross Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Basingstoke and North Hampshire NHS Foundation Trust
City
Basingstoke
State/Province
England
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Royal United Hospital
City
Bath
State/Province
England
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
Frenchay Hospital
City
Bristol
State/Province
England
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
Addenbrooke's Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Halton Hospital
City
Cheshire
State/Province
England
ZIP/Postal Code
WA7 2DA
Country
United Kingdom
Facility Name
Essex County Hospital
City
Colchester
State/Province
England
ZIP/Postal Code
C03 3NB
Country
United Kingdom
Facility Name
Dorset County Hospital
City
Dorchester
State/Province
England
ZIP/Postal Code
DT1 2JY
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
State/Province
England
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Gateshead
State/Province
England
ZIP/Postal Code
NE9 6SX
Country
United Kingdom
Facility Name
Diana Princess of Wales Hospital
City
Grimsby
State/Province
England
ZIP/Postal Code
DN33 2BA
Country
United Kingdom
Facility Name
UCL Cancer Institute
City
Hampstead, London
State/Province
England
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield, West Yorks
State/Province
England
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
King George Hospital
City
Ilford, Essex
State/Province
England
ZIP/Postal Code
IG3 8YB
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Kidderminster Hospital
City
Kidderminster Worcestershire
State/Province
England
ZIP/Postal Code
DY11 6RJ
Country
United Kingdom
Facility Name
Yorkshire Regional Clinical Trials & Research Unit
City
Leeds
State/Province
England
ZIP/Postal Code
LS16 6QB
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Whipps Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Newham University Hospital
City
London
State/Province
England
ZIP/Postal Code
E13 85L
Country
United Kingdom
Facility Name
Homerton University Hospital
City
London
State/Province
England
ZIP/Postal Code
E9 6SR
Country
United Kingdom
Facility Name
Saint Bartholomew's Hospital
City
London
State/Province
England
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Helen Rollason Cancer Care Centre at North Middlesex Hospital
City
London
State/Province
England
ZIP/Postal Code
N18 1QX
Country
United Kingdom
Facility Name
Whittington Hospital
City
London
State/Province
England
ZIP/Postal Code
N19 5NF
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Luton and Dunstable Hospital
City
Luton-Bedfordshire
State/Province
England
ZIP/Postal Code
LU4 0DZ
Country
United Kingdom
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
England
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
North Manchester General Hospital - Penine Actute Hospitals Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M8 6RB
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre at Mount Vernon Hospital
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
State/Province
England
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Peterborough Hospitals Trust
City
Peterborough
State/Province
England
ZIP/Postal Code
PE3 6DA
Country
United Kingdom
Facility Name
Dorset Cancer Centre
City
Poole Dorset
State/Province
England
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Portsmouth Oncology Centre at Saint Mary's Hospital
City
Portsmouth Hants
State/Province
England
ZIP/Postal Code
PO3 6AD
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
State/Province
England
ZIP/Postal Code
RM7 OBE
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
State/Province
England
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Scunthorpe General Hospital
City
Scunthorpe
State/Province
England
ZIP/Postal Code
DN15 7BH
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro, Cornwall
State/Province
England
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Kent and Sussex Hospital
City
Tunbridge Wells, Kent
State/Province
England
ZIP/Postal Code
TN4 8AT
Country
United Kingdom
Facility Name
Warrington Hospital NHS Trust
City
Warrington
State/Province
England
ZIP/Postal Code
WA5 1QG
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
State/Province
England
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Yeovil District Hospital
City
Yeovil - Somerset
State/Province
England
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Dumfries & Galloway Royal Infirmary
City
Dumfries
State/Province
Scotland
ZIP/Postal Code
DG1 4AP
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Queen Margaret Hospital - Dunfermline
City
Dunfermline
State/Province
Scotland
ZIP/Postal Code
KY12 0SU
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Falkirk and District Royal Infirmary
City
Falkirk
State/Province
Scotland
ZIP/Postal Code
FK1 5QE
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Royal Infirmary - Castle
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Southern General Hospital
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
State/Province
Scotland
ZIP/Postal Code
1V2 3UJ
Country
United Kingdom
Facility Name
Crosshouse Hospital
City
Kilmarnock
State/Province
Scotland
ZIP/Postal Code
KA2 OBE
Country
United Kingdom
Facility Name
Royal Alexandra Hospital
City
Paisley
State/Province
Scotland
Country
United Kingdom
Facility Name
Bronglais District General Hospital
City
Aberystwyth
State/Province
Wales
ZIP/Postal Code
SY23 1ER
Country
United Kingdom
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
Velindre Cancer Center at Velindre Hospital
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Withybush General Hospital
City
Haverfordwest
State/Province
Wales
ZIP/Postal Code
SA61 2PZ
Country
United Kingdom
Facility Name
Royal Glamorgan Hospital
City
Lhantrisant
State/Province
Wales
ZIP/Postal Code
CF72 8XR
Country
United Kingdom
Facility Name
Glan Clwyd Hospital
City
Rhyl, Denbighshire
State/Province
Wales
ZIP/Postal Code
LL 18 5UJ
Country
United Kingdom
Facility Name
South West Wales Cancer Institute
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Goserelin in Preventing Early Menopause in Premenopausal Women Undergoing Chemotherapy for Stage I, Stage II, or Stage III Breast Cancer
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