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 |
| EudraCT/CTIS number | 2004-000133-11 |
| ClinicalTrials.gov number | NCT00427245 |
| Secondary identifying numbers | BR 0301 |
- 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
Contact information
Prof Robert Leonard
Scientific
Scientific
Director - South Wales Cancer Institute
University of Wales
Singleton Hospital
Sketty Lane
Sketty
Swansea
SA2 8AQ
United Kingdom
| abc@email.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2004 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 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
SA2 8AQ
United Kingdom
Sponsor information
Clinical Trials Advisory and Awards Committee (CTAAC) (UK)
Research organisation
Research organisation
Cancer Research UK
PO Box 123
London
WC2A 3PX
United Kingdom
"ROR" |
https://ror.org/054225q67 |
|---|
Funders
Funder type
Research organisation
Clinical Trials Advisory and Awards Commitee (CTAAC) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
| Plain English results | 26/10/2022 | 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.
