Ovarian Protection Trial in Oestrogen Non-responsive Premenopausal Breast Cancer Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy - 'OPTION'
Principal Investigator: Professor Lesley Fallowfield
Co-investigator: Professor Robert Leonard, Consultant Oncologist, Clinical Director for Cancer, Hammersmith Hospital, London
Lead Researcher: Louise Parlour
Data Manager: Carolyn Langridge
Funded by Cancer Research UK (2004-2009)
Background and aims
The primary aim of the OPTION trial is to determine the impact of goserelin on the incidence of premature ovarian failure following chemotherapy for operable breast cancer, defined by clinical assessment and endocrine assay. It is hoped that a temporary ovarian suppression may protect ovarian function which would have physical and potentially emotional benefits for premenopausal women unfortunate enough to develop breast cancer. The QoL of patients allocated to 6 - 8 cycles of cyclophosphamide and/or anthracylcine containing polychemotherapy, are compared with that of patients allocated to the above plus goserelin. QoL is measured using the FACT-B+ES (Functional Assessment of Cancer Therapy Breast with the Endocrine Subscale). Patients from both groups are assessed at baseline (prior to randomisation) and followed up at 3, 6, 12, 18, 24 months and yearly until 5 years, or until confirmation of disease recurrence.