On 2 January 2020, the POSITIVE study (public name: BIG Time for Baby) met its target accrual, enrolling 518 patients from 203 centres from 20 countries around the world. The initial target accrual was 500 patients, but due to the interest shown by young women in this study, women who already had appointments with their oncologists to enrol in the study were still able to participate.
POSITIVE represents a unique opportunity to allow young women who have had breast cancer to plan and try to become pregnant without waiting many years after completing their endocrine treatment.
The study expects to provide an answer to the question of whether women can interrupt their endocrine treatment to try to have a baby, without increasing the risk of cancer recurrence.
The study has recruited pre-menopausal women, aged 42 years and younger, with ER+ early breast cancer who have received endocrine therapy for 18 to 30 months and who wish to interrupt endocrine therapy to become pregnant.
During the study, they take a three-month break in treatment before attempting pregnancy and stop treatment for up to two years to allow time for conception, delivery and breastfeeding (or potential failure to conceive). Endocrine therapy then restarts and continues for the duration of treatment. Women will be followed up for 10 years after enrolment.
As of 31 December 2019, 125 healthy babies had already been born.