Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer (POSITIVE)
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|ClinicalTrials.gov Identifier: NCT02308085|
Recruitment Status : Recruiting
First Posted : December 4, 2014
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Early Breast Cancer||Other: Endocrine therapy interruption||Not Applicable|
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 Type :||Interventional|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2028|
Experimental: Endocrine therapy interruption
Endocrine therapy interruption after having completed between ≥ 18 months and ≤ 30 months.
Other: 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.
- Breast Cancer free interval (BCFI) [ Time Frame: From enrollment until the first invasive BC event, assessed up to 14 years ]Kaplan-Meier Analysis
- Information on Menstruation recovery and pattern [ Time Frame: Up to 24 months after enrollment ]Menstrual diary
- Pregnancy rate (determined by pregnancy test) [ Time Frame: Up to 24 months after enrollment ]Pregnancy test
- Pregnancy outcome [ Time Frame: Up to 33 months after enrollment ]Labor and delivery Information, full term pregnancy, caesarean section, abortion, miscarriage, ectopic, stillbirth rates.
- Offspring outcome [ Time Frame: Up to 33 months after enrollment ]Collect information on preterm birth, low birth weight, births defects rates.
- Breastfeeding pattern [ Time Frame: 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) [ Time Frame: Up to 24 months after enrollment ]ART use will be tabulated
- Distant recurrence-free interval (DRFI) [ Time Frame: Time from enrollment in the study to the first breast cancer recurrence in a distant site, assessed up to 14 years ]Kaplan-Meier Analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308085
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|Study Chair:||Olivia Pagani, MD||Oncology Institue of Southern Switzerland (IOSI)|