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.
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
42 Years
Healthy volunteers
No
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.
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.
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 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.
Primary outcome measure(s)
Breast Cancer free interval (BCFI) — From enrollment until the first invasive BC event, assessed up to 14 years Kaplan-Meier Analysis
Trial sites (211)
Facility
City
Region
Status
Cedars Sinai Medical Centre
Los Angeles
California
Stanford Cancer Institute
Palo Alto
California
Sharp Memorial Hospital
San Diego
California
University of Colorado Cancer Centre - Anschutz Cancer Pavilion
Aurora
Colorado
Rocky Mountain Cancer Center
Boulder
Colorado
SCL Health Saint Joseph Hospital
Denver
Colorado
Poudre Valley Hospital
Fort Collins
Colorado
Smilow Cancer Hospital-Derby Care Center
Derby
Connecticut
Smilow Cancer Hospital Care Center-Fairfield
Fairfield
Connecticut
Smilow Cancer Hospital Care Center at Saint Francis
Hartford
Connecticut
Yale University - Yale Cancer Centre
New Haven
Connecticut
Yale-New Haven Hospital North Haven Medical Center
North Haven
Connecticut
Smilow Cancer Hospital-Orange Care Center
Orange
Connecticut
Smilow Cancer Hospital-Torrington Care Center
Torrington
Connecticut
Smilow Cancer Hospital Care Center-Trumbull
Trumbull
Connecticut
Smilow Cancer Hospital-Waterbury Care Center
Waterbury
Connecticut
Helen F. Graham Cancer Center
Newark
Delaware
Christiana Care Health System-Christiana Hospital
Newark
Delaware
Medical Oncology Hematology Consultants PA
Newport
Delaware
Regional Hematology Oncology Practice Associates
Newport
Delaware
Georgetown University Hospital
Washington D.C.
District of Columbia
Sibley Memorial Hospital
Washington D.C.
District of Columbia
Emory University Hospital Midtown
Atlanta
Georgia
Emory University
Atlanta
Georgia
Straub Clinic and Hospital
Honolulu
Hawaii
OnCare Hawaii Inc - POB I
Honolulu
Hawaii
Queen's Medical Centre
Honolulu
Hawaii
OnCare Hawaii-Kuakini
Honolulu
Hawaii
John H Stroger Jr Hospital of Cook County
Chicago
Illinois
Carle on Vermilion
Danville
Illinois
Carle Physician Group - Effingham
Effingham
Illinois
NorthShore University HealthSystem-Evanston Hospital
Evanston
Illinois
Northwestern University
Evanston
Illinois
NorthShore University Health System - Glenbrook Hospital
Glenview
Illinois
NorthShore Unversity Health System - Highland Park Hospital
Highland Park
Illinois
Mattoon Charleston Primary Care
Mattoon
Illinois
NorthShore Medical Centre
Skokie
Illinois
Carle Cancer Centre
Urbana
Illinois
The Carle Foundation Hospital
Urbana
Illinois
Indiana University
Indianapolis
Indiana
+ 171 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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