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

Breast Cancer Clinical Trial

Official title:

Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427245
• Other study ID #: CRUK-OPTION
• Secondary ID: CDR0000526368EUD
• Status: Completed
• Phase: Phase 3
• First received: January 25, 2007
• Last updated: August 6, 2013
• Start date: August 2004

Study information

• Verified date: May 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Infertility
• Menopausal Symptoms

Intervention

Drug:
• cyclophosphamide

• goserelin acetate

Procedure:
• adjuvant therapy

• fertility assessment and management

• neoadjuvant therapy

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Bronglais District General Hospital	Aberystwyth	Wales
United Kingdom	Ysbyty Gwynedd	Bangor	Wales
United Kingdom	Basingstoke and North Hampshire NHS Foundation Trust	Basingstoke	England
United Kingdom	Royal United Hospital	Bath	England
United Kingdom	Frenchay Hospital	Bristol	England
United Kingdom	Addenbrooke's Hospital	Cambridge	England
United Kingdom	Velindre Cancer Center at Velindre Hospital	Cardiff	Wales
United Kingdom	Halton Hospital	Cheshire	England
United Kingdom	Essex County Hospital	Colchester	England
United Kingdom	Dorset County Hospital	Dorchester	England
United Kingdom	Russells Hall Hospital	Dudley	England
United Kingdom	Dumfries & Galloway Royal Infirmary	Dumfries	Scotland
United Kingdom	Ninewells Hospital	Dundee	Scotland
United Kingdom	Queen Margaret Hospital - Dunfermline	Dunfermline	Scotland
United Kingdom	Edinburgh Cancer Centre at Western General Hospital	Edinburgh	Scotland
United Kingdom	Falkirk and District Royal Infirmary	Falkirk	Scotland
United Kingdom	Queen Elizabeth Hospital	Gateshead	England
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	Royal Infirmary - Castle	Glasgow	Scotland
United Kingdom	Southern General Hospital	Glasgow	Scotland
United Kingdom	Diana Princess of Wales Hospital	Grimsby	England
United Kingdom	UCL Cancer Institute	Hampstead, London	England
United Kingdom	Withybush General Hospital	Haverfordwest	Wales
United Kingdom	Huddersfield Royal Infirmary	Huddersfield, West Yorks	England
United Kingdom	King George Hospital	Ilford, Essex	England
United Kingdom	Raigmore Hospital	Inverness	Scotland
United Kingdom	Ipswich Hospital	Ipswich	England
United Kingdom	Kidderminster Hospital	Kidderminster Worcestershire	England
United Kingdom	Crosshouse Hospital	Kilmarnock	Scotland
United Kingdom	Yorkshire Regional Clinical Trials & Research Unit	Leeds	England
United Kingdom	Royal Glamorgan Hospital	Lhantrisant	Wales
United Kingdom	Royal Liverpool University Hospital	Liverpool	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	Guy's Hospital	London	England
United Kingdom	Helen Rollason Cancer Care Centre at North Middlesex Hospital	London	England
United Kingdom	Homerton University Hospital	London	England
United Kingdom	Newham University Hospital	London	England
United Kingdom	Saint Bartholomew's Hospital	London	England
United Kingdom	St. George's Hospital	London	England
United Kingdom	Whipps Cross Hospital	London	England
United Kingdom	Whittington Hospital	London	England
United Kingdom	Luton and Dunstable Hospital	Luton-Bedfordshire	England
United Kingdom	Maidstone Hospital	Maidstone	England
United Kingdom	Christie Hospital	Manchester	England
United Kingdom	North Manchester General Hospital - Penine Actute Hospitals Trust	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology	Merseyside	England
United Kingdom	Mount Vernon Cancer Centre at Mount Vernon Hospital	Northwood	England
United Kingdom	Norfolk and Norwich University Hospital	Norwich	England
United Kingdom	Royal Alexandra Hospital	Paisley	Scotland
United Kingdom	Peterborough Hospitals Trust	Peterborough	England
United Kingdom	Dorset Cancer Centre	Poole Dorset	England
United Kingdom	Portsmouth Oncology Centre at Saint Mary's Hospital	Portsmouth Hants	England
United Kingdom	Glan Clwyd Hospital	Rhyl, Denbighshire	Wales
United Kingdom	Oldchurch Hospital	Romford	England
United Kingdom	Salisbury District Hospital	Salisbury	England
United Kingdom	Scunthorpe General Hospital	Scunthorpe	England
United Kingdom	Cancer Research Centre at Weston Park Hospital	Sheffield	England
United Kingdom	Southampton General Hospital	Southampton	England
United Kingdom	South West Wales Cancer Institute	Swansea	Wales
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

Sponsors (1)

Lead Sponsor	Collaborator
Anglo Celtic Cooperative Oncology Group

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months
Secondary	Incidence of menopausal symptoms
Secondary	Quality of life
Secondary	Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers
Secondary	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
Secondary	Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy
Secondary	Incidence of pregnancy