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

Not Applicable

Active, not recruiting

• Conditions: Early Breast Cancer

• Registration Number: NCT02308085
• Lead Sponsor: ETOP IBCSG Partners Foundation

Brief 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.

Detailed Description

Recent decades have witnessed a delay in childbearing for a variety of reasons including cultural, educational, and professional. As a consequence, breast cancer in young women often occurs before the completion of reproductive plans. Infertility has a significant impact on quality of life, resulting in substantial distress in younger women with breast cancer and influencing treatment decisions in a consistent proportion of patients.The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence.For women desiring pregnancy after a breast cancer, 5-10 years of endocrine therapy may substantially reduce the chance of conception; however, a shorter duration of endocrine therapy in this population has not been studied in a prospective manner.

Birth outcome after breast cancer has not been shown to be different from that of the normal population, but increased risks of delivery complications, cesarean section, preterm birth and low birth weight have been reported.

Endocrine agents are potentially teratogenic: taking into account their median half-life, waiting 3 months after their interruption before attempting conception is considered safe.

The limited evidence available on breastfeeding after breast cancer reports successful lactation from the treated breast in approximately 30% of women without detrimental effect on survival. No prospective definitive data are available.

Study Timeline

• Study First Submitted: 2014-11-21
• Study First Submitted QC: 2014-12-02
• Study Start: 2014-12-04
• Study First Posted: 2014-12-04
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-05
• Primary Completion: 2025-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 518

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Breast Cancer free interval (BCFI)	From enrollment until the first invasive BC event, assessed up to 14 years	Kaplan-Meier Analysis

Secondary Outcome Measures

Name	Time	Method
Offspring outcome	Up to 33 months after enrollment	Collect information on preterm birth, low birth weight, births defects rates.
Distant recurrence-free interval (DRFI)	Time from enrollment in the study to the first breast cancer recurrence in a distant site, assessed up to 14 years	Kaplan-Meier Analysis
Information on Menstruation recovery and pattern	Up to 24 months after enrollment	Menstrual diary
Pregnancy outcome	Up to 33 months after enrollment	Labor and delivery Information, full term pregnancy, caesarean section, abortion, miscarriage, ectopic, stillbirth rates.
Pregnancy rate (determined by pregnancy test)	Up to 24 months after enrollment	Pregnancy test
Breastfeeding pattern	Up to 36 months after enrollment	Analysis of pattern e.g Duration, use of ipsilateral breast if previous breast conservation, side exclusivity
Use of assisted reproductive Technology (ART)	Up to 24 months after enrollment	ART use will be tabulated

Trial Locations

Locations (208)

Cedars Sinai Medical Centre; 🇺🇸 Los Angeles, California, United States

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

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