Contact information
Type
Scientific
Primary contact
Prof Robert Leonard
ORCID ID
Contact details
Director - South Wales Cancer Institute
University of Wales
Singleton Hospital
Sketty Lane
Sketty
Swansea
SA2 8AQ
United Kingdom
-
abc@email.com
Additional identifiers
EudraCT number
2004-000133-11
ClinicalTrials.gov number
NCT00427245
Protocol/serial number
BR 0301
Study information
Scientific title
Ovarian Protection Trial In Oestrogen Non-responsive premenopausal breast cancer patients receiving adjuvant or neo-adjuvant chemotherapy
Acronym
OPTION
Study hypothesis
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.
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast Cancer
Intervention
Treatment A: Chemotherapy
Treatment B: Chemotherapy plus Goserelin
Intervention type
Drug
Phase
Not Applicable
Drug names
Goserelin
Primary 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
1. Incidence of menopausal symptoms
2. Quality of life
3. Bone mineral density loss as measured by dual energy X-ray absorptiometry scans at 12, 24, and 36 months and by serum biomarkers
4. Hormone levels (including follicle-stimulating hormone, luteinizing hormone, beta-inhibin, and estradiol) as measured after course three, after course six or eight (depending on chemotherapy regimen), at 9 and 12 months, and then annually for up to five years
5. Menstruation history as measured by patient menstrual diary for 24 months from the start of chemotherapy
6. Incidence of pregnancy
Overall trial start date
01/01/2004
Overall trial end date
31/12/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Disease characteristics:
1. Histologically confirmed invasive breast cancer
2. Stages I-IIIB with node-positive or -negative disease (N0-2)
3. Operable disease
4. Must meet one of the following criteria:
4.1. Has undergone mastectomy or breast-conserving surgery with complete excision of primary tumor within the past eight weeks
4.2. Scheduled to receive neoadjuvant chemotherapy
4.3. No metastatic breast cancer, including supraclavicular fossa metastases
4.4. Hormone receptor status meeting one of the following criteria:
4.4.1. Estrogen receptor (ER) and progesterone receptor poor or negative AND not a candidate for adjuvant endocrine therapy
4.4.2. ER positive AND no requirement for ovarian suppression as a necessary part of treatment
Patient characteristics:
1. Female
2. Premenopausal with regular menses in the 12 months preceding surgery
3. No other prior or concurrent invasive malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
4. Suitable fitness status for chemotherapy
5. Adequate hepatic, renal, and bone marrow function
6. Not pregnant or nursing
7. Fertile patients must use effective contraception
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
400
Participant exclusion criteria
Prior chemotherapy or endocrine therapy.
Recruitment start date
01/01/2004
Recruitment end date
31/12/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Singleton Hospital
Swansea
SA2 8AQ
United Kingdom
Funders
Funder type
Research organisation
Funder name
Clinical Trials Advisory and Awards Commitee (CTAAC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4782022/ (added 08/02/2019)