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Trial Summary

Protocol No.A221405/IBCSG48-POSITIVE
StatusOPEN TO ACCRUAL
Principal InvestigatorBallinger, Tarah
ScopeNational
PhaseNA
Age GroupAdult
TitleA study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy(POSITIVE)
DescriptionThe best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Has received adjuvant endocrine therapy (SERM alone, GnRH analogue plus SERM or AI) for ≥18 months but ≤30 months for early breast cancer. Note: Patients who have received neo/adjuvant endocrine treatment within a clinical trial and patients who have received pharmaco-prevention are eligible.
  • Patient wishes to become pregnant. Note: Patients who have undergone oocyte/embryo/ovarian tissue cryopreservation at breast cancer diagnosis and/or have a previous history of assisted reproductive technology (ART) are eligible.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesBreast
Participating InstitutionsIndiana University (IU)
  • Eskenazi Hospital
  • Indiana University Hospital / IU Simon Cancer Center
  • Spring Mill Medical Center
Treatment TypeTreatment
ContactPhone: (317) 278-5632
Email: iutrials@iu.edu