Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer
NCT02308085 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- OTHER Endocrine therapy interruption
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center — Derby
- Smilow Cancer Hospital Care Center-Fairfield — Fairfield
- Smilow Cancer Hospital Care Center at Saint Francis — Hartford
- Yale University - Yale Cancer Centre — New Haven
- Yale-New Haven Hospital North Haven Medical Center — North Haven
- Smilow Cancer Hospital-Orange Care Center — Orange
- Smilow Cancer Hospital-Torrington Care Center — Torrington
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull
- Smilow Cancer Hospital-Waterbury Care Center — Waterbury
Colorado
- University of Colorado Cancer Centre - Anschutz Cancer Pavilion — Aurora
- Rocky Mountain Cancer Center — Boulder
- SCL Health Saint Joseph Hospital — Denver
- Poudre Valley Hospital — Fort Collins
Delaware
- Helen F. Graham Cancer Center — Newark
- Christiana Care Health System-Christiana Hospital — Newark
- Medical Oncology Hematology Consultants PA — Newport
- Regional Hematology Oncology Practice Associates — Newport
California
- Cedars Sinai Medical Centre — Los Angeles
- Stanford Cancer Institute — Palo Alto
- Sharp Memorial Hospital — San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2014-12-04 |
| Est. Completion | 2028-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02308085
The ClinicalTrials.gov registry entry for NCT02308085 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 518 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ETOP IBCSG Partners Foundation, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Early Breast Cancer appearing as the primary indexed condition, and to 1 intervention — of which Endocrine therapy interruption is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02308085 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Connecticut, Colorado, Delaware. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02308085 about?
NCT02308085 is a clinical study titled "Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer". 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...
What is the current status of trial NCT02308085?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 518 participants. The study started on 2014-12-04. Estimated completion is 2028-12.
What conditions does trial NCT02308085 study?
This clinical trial studies the following conditions: Early Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02308085?
The interventions under investigation include: Endocrine therapy interruption (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02308085?
This trial is sponsored by ETOP IBCSG Partners Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02308085 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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