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Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer

NCT02308085 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 518

Last updated 2026-02-09

No results posted yet for this study

Summary

The 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.

Conditions

  • Early Breast Cancer

Interventions

OTHER

Endocrine therapy interruption

3 months wash-out between treatment interruption and pregnancy attempt. Up to 2 years interruption to allow pregnancy, delivery, breastfeeding or failure to conceive. Endocrine therapy resumption. Completion of full duration of endocrine therapy according to individual risk, institutional policy or patient's preference.

Sponsors & Collaborators

  • Alliance for Clinical Trials in Oncology

    collaborator OTHER

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • Breast International Group

    collaborator OTHER

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Olivia Pagani, MD · Oncology Institue of Southern Switzerland (IOSI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-04
Primary Completion
2025-05-15
Completion
2028-12-31

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • France
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Lebanon
  • Netherlands
  • Norway
  • Portugal
  • Serbia
  • Slovenia
  • South Korea
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02308085 on ClinicalTrials.gov