A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy (POSITIVE)

Not Applicable

• Conditions: Premenopausal endocrine responsive early breast cancer

• Registration Number: JPRN-UMIN000019929
• Lead Sponsor: International Breast Cancer Study Group (IBCSG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-02
• Study Completion: 2020-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

Not provided

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: Not specified

Primary Outcome Measures

Name	Time	Method
Breast Cancer free interval (BCFI) defined as the time from enrollment in the study to the first invasive BC event (local, regional, or distant recurrence or a new invasive contralateral BC).

Secondary Outcome Measures

Name	Time	Method
-Menstruation recovery and pattern. -Pregnancy (determined by pregnancy test). -Pregnancy outcome: full term pregnancy, caesarean section, abortion, miscarriage, ectopic, stillbirth. -Offspring outcome: preterm birth, low birth weight, birth defects. -Breastfeeding; pattern of breastfeeding (duration, use ipsilateral breast if previous breast conservation, side exclusivity). -Use of assisted reproductive technology (ART). -Adherence to endocrine treatment assessed by: -- Treatment resumption after the ~2 year ET break. -- Total duration of at least 5 years of ET. -Distant recurrence-free interval (DRFI), defined as the time from enrollment in the study to the first BC recurrence in a distant site, excluding second (non-breast) primary cancers and contralateral breast cancer.