Ovarian Protection Trial In Oestrogen Non-responsive premenopausal breast cancer patients receiving adjuvant or neo-adjuvant chemotherapy

ISRCTN	ISRCTN84856516
DOI	https://doi.org/10.1186/ISRCTN84856516
ClinicalTrials.gov (NCT)	NCT00427245
Clinical Trials Information System (CTIS)	2004-000133-11
Protocol serial number	BR 0301
Sponsor	Clinical Trials Advisory and Awards Committee (CTAAC) (UK)
Funder	Clinical Trials Advisory and Awards Commitee (CTAAC) (UK)

Submission date: 21/01/2004
Registration date: 10/03/2004
Last edited: 26/10/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-ovarian-protection-for-premenopausal-women-having-chemotherapy-for-breast-cancer

Contact information

Prof Robert Leonard
Scientific

Director - South Wales Cancer Institute
University of Wales
Singleton Hospital
Sketty Lane
Sketty
Swansea
SA2 8AQ
United Kingdom

Email	abc@email.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Ovarian Protection Trial In Oestrogen Non-responsive premenopausal breast cancer patients receiving adjuvant or neo-adjuvant chemotherapy
Study acronym	OPTION
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Breast Cancer
Intervention	Treatment A: Chemotherapy Treatment B: Chemotherapy plus Goserelin
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Goserelin
Primary outcome measure(s)	Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months.
Key secondary outcome measure(s)	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
Completion date	31/12/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	400
Total final enrolment	227
Key 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
Key exclusion criteria	Prior chemotherapy or endocrine therapy.
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2004

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Singleton Hospital

Swansea
SA2 8AQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2016	08/02/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results			26/10/2022	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.
19/03/2020: EudraCT number added.
08/02/2019: Publication reference added.
09/11/2015: no publications found on PubMed.