Ovarian Protection Trial In Premenopausal Breast Cancer Patients [OPTION]
- Compare the incidence of premature ovarian failure after chemotherapy in premenopausal
women with stage I-III breast cancer treated with goserelin vs no goserelin .
- Compare the quality of life of patients treated with these regimens.
- Compare menopausal symptoms in patients treated with these regimens.
- Compare bone mineral density loss in patients treated with these regimens.
- Compare hormone levels in patients treated with these regimens.
- Compare menstruation in patients treated with these regimens.
- Compare the incidence of pregnancy in patients treated with these regimens.
OUTLINE: This is a randomized, open-label, prospective, parallel group, multicenter study.
Patients are stratified according to age (≤ 40 years vs > 40 years) and participating
center. Patients are randomized to 1 of 2 treatment arms.
Arm I (chemotherapy alone): Patients receive neoadjuvant or adjuvant cyclophosphamide-
and/or anthracycline-containing chemotherapy. Treatment continues for 6-8 courses in the
absence of disease progression or unacceptable toxicity.
Arm II (chemotherapy plus goserelin for ovarian function suppression): Patients receive
neoadjuvant or adjuvant chemotherapy as in arm I. Patients also receive goserelin
subcutaneously every 3-4 weeks beginning 1-3 weeks before the start of chemotherapy.
Treatment with goserelin repeats every 3-4 weeks until completion of chemotherapy.
Quality of life is assessed at baseline, at 3, 6, 12, 18, and 24 months, and then annually
for up to 5 years.
After completion of study therapy, patients are followed periodically for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Rate of premature menopause, defined as cessation of menses during a course of chemotherapy with no recovery for at least 12 months
Robert C.F. Leonard, MD, BS, MB
Charing Cross Hospital