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

Running, not enrolling · Not applicable

Conditions studied: Early Breast Cancer

In brief

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.

Key facts

Study ID

NCT02308085

Run by

ETOP IBCSG Partners Foundation

People needed

518

Starts

2014-12-04

Expected to finish

2028-12-01

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 and ≤ 42 years at enrollment.
• 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.
• The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment.
• 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.
• Breast cancer for which patient is receiving endocrine therapy must have been histologically-proven stage I-III, endocrine-responsive (i.e., estrogen and/or progesterone receptor positive, according to local definition of positive, determined using immunohistochemistry (IHC)), and treated with curative intent.
• Note:
• Patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible.
• Patient with invasive breast cancer or synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) during pregnancy are eligible.
• Patients with BRCA1/2 mutations are eligible.
• Patients could have received neo/adjuvant chemotherapy, or other systemic therapy (e.g., neo/adjuvant HER2-targeted therapy) according to institutional policy and patient's desire.
• Patient must be premenopausal at breast cancer diagnosis, as determined locally and documented in patient record.
• Patient must be without clinical evidence of loco-regional and distant disease, as evaluated according to institutional assessment standards and documented in the patient record.
• Written informed consent (IC) for trial participation must be signed and dated by the patient and the investigator prior to enrollment.
• Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial.
• The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines.
• Patient must be accessible for follow-up.

You may not qualify if…

• Post-menopausal patients at BC diagnosis, as determined locally.
• History of hysterectomy, bilateral oophorectomy or ovarian irradiation.
• Patients with current local, loco-regional relapse and/or distant metastatic breast cancer.
• Patients with a history of prior (ipsi- and/or contralateral) invasive BC.
• Patients with previous or concomitant non-breast invasive malignancy.
• Exceptions are limited exclusively to patients with the following previous malignancies, if adequately treated: basal or squamous cell carcinoma of the skin, in situ non-breast carcinoma, contra- or ipsilateral in situ breast carcinoma, stage Ia carcinoma of the cervix.
• Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety.
• Patients with a history of noncompliance to medical treatments and/or considered potentially unreliable.
• Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements.

Where it is running

• Stanford Cancer Institute — Palo Alto, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• University of Colorado Cancer Centre - Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Rocky Mountain Cancer Center — Boulder, Colorado, United States
• SCL Health Saint Joseph Hospital — Denver, Colorado, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut, United States
• Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• Yale University - Yale Cancer Centre — New Haven, Connecticut, United States
• Yale-New Haven Hospital North Haven Medical Center — North Haven, Connecticut, United States
• Smilow Cancer Hospital-Orange Care Center — Orange, Connecticut, United States
• Smilow Cancer Hospital-Torrington Care Center — Torrington, Connecticut, United States
• Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States
• Smilow Cancer Hospital-Waterbury Care Center — Waterbury, Connecticut, United States
• Helen F. Graham Cancer Center — Newark, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Medical Oncology Hematology Consultants PA — Newport, Delaware, United States
• Regional Hematology Oncology Practice Associates — Newport, Delaware, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory University — Atlanta, Georgia, United States
• Straub Clinic and Hospital — Honolulu, Hawaii, United States
• Cedars Sinai Medical Centre — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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