Condition category
Cancer
Date applied
21/01/2004
Date assigned
10/03/2004
Last edited
09/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

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 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

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

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

Sponsor information

Organisation

Clinical Trials Advisory and Awards Committee (CTAAC) (UK)

Sponsor details

Cancer Research UK
PO Box 123
London
WC2A 3PX
United Kingdom

Sponsor type

Research organisation

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

09/11/2015: no publications found on PubMed.