-
POSITIVE (JBCRG-23)
GLOBAL This trial is a collaborative study with IBCSG.
A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy
- Status
- No Longer Recruiting
- Objectives
- To assess the risk of breast cancer relapse associated with temporary interruption of endocrine therapy (ET) to permit pregnancy.
- Subjects
- Endpoints
- Primary endpoint: Breast cancer free interval (BCFI) defined as the time from enrollment in the study to the first invasive BC event (local, regional, or distant recurrence or a new invasive contralateral BC). Secondary endpoints: ・Menstruation recovery and pattern. ・Pregnancy (determined by pregnancy test). ・Pregnancy outcome: full term pregnancy, caesarean section, abortion,miscarriage, ectopic, stillbirth. ・Offspring outcome: preterm birth, low birth weight, birth defects. ・Breastfeeding; pattern of breastfeeding (duration, use ipsilateral breast if previous breast conservation, side exclusivity). ・Use of assisted reproductive technology (ART). ・Adherence to endocrine treatment assessed by: - Treatment resumption after the ~2 year ET break. - Total duration of at least 5 years of ET. ・Distant recurrence-free interval (DRFI), defined as the time from enrollment in the study to the first BC recurrence in a distant site,excluding second.
- Trial Period
- Jul.,2014～Jun.,2028/IBCSG
- Lead Principal Investigator
- Chikako Shimizu(National Cancer Center Hospital, Department of Breast and Medical Oncology
- Target Sample Size
- 50(Japan)/500(Global)
- Regimen
- Source of Funding
- International Breast Cancer Study Group (IBCSG)
- Conference Presentation
- Articles and Publications
- Memo
- COI Disclosure