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

Not Recruiting

Trial ID: NCT02308085


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.

Official Title

A Study Evaluating the Pregnancy Outcomes and Safety of Interrupting Endocrine Therapy for Young Women With Endocrine Responsive Breast Cancer Who Desire Pregnancy

Stanford Investigator(s)

Irene Wapnir, MD
Irene Wapnir, MD

Professor of Surgery (General Surgery)


Inclusion Criteria:

   - 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.


   - 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.

Exclusion Criteria:

   - 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

   - 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

   - 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.


other: Endocrine therapy interruption

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kathryn Bucknell

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