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Endocrine Therapy Interruption for Breast Cancer During Pregnancy (POSITIVE Trial)

N/A
Waitlist Available
Research Sponsored by International Breast Cancer Study Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have received neo/adjuvant endocrine treatment within a clinical trial and patients who have received pharmaco-prevention are eligible
Patient wishes to become pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until the first invasive bc event, assessed up to 14 years
Awards & highlights

POSITIVE Trial Summary

This trial is investigating whether or not temporarily interrupting endocrine therapy, in order to allow pregnancy, increases the risk of breast cancer recurrence. The study will also evaluate different indicators related to fertility, pregnancy, and breast cancer biology.

Who is the study for?
This trial is for premenopausal women aged 18-42 who had breast cancer and wish to become pregnant. They must have completed at least 18 months of endocrine therapy, be without current cancer evidence, and agree to follow-up and data handling. Women with BRCA mutations or prior treatments within a clinical trial are eligible.Check my eligibility
What is being tested?
The study tests the safety of temporarily stopping endocrine therapy in young women who want to get pregnant after breast cancer treatment. It will assess the risk of cancer recurrence and examine fertility, pregnancy outcomes, and psychological well-being related to fertility concerns.See study design
What are the potential side effects?
Since this trial involves interrupting treatment rather than administering new drugs, it does not directly test side effects; however, potential risks include an increased chance of breast cancer recurrence during the interruption period.

POSITIVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been part of a clinical trial for hormone therapy or received preventive drug treatment.
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I want to become pregnant.
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I may have had chemotherapy or other treatments for my cancer before or after surgery, based on my doctor's advice and my choice.
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I was diagnosed with cancer in both breasts within the last 2 months.
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I am between 18 and 42 years old.
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I stopped my hormone therapy for cancer less than a month ago.
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I was premenopausal when diagnosed with breast cancer.
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My records show no signs of cancer spread in my body.
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I have a BRCA1 or BRCA2 gene mutation.
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I have taken hormone therapy for breast cancer for 18 to 30 months.
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I was diagnosed with breast cancer during my pregnancy.

POSITIVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until the first invasive bc event, assessed up to 14 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until the first invasive bc event, assessed up to 14 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Breast Cancer free interval (BCFI)
Secondary outcome measures
Breastfeeding pattern
Distant recurrence-free interval (DRFI)
Information on Menstruation recovery and pattern
+4 more

POSITIVE Trial Design

1Treatment groups
Experimental Treatment
Group I: Endocrine therapy interruptionExperimental Treatment1 Intervention
Endocrine therapy interruption after having completed between ≥ 18 months and ≤ 30 months.

Find a Location

Who is running the clinical trial?

International Breast Cancer Study GroupLead Sponsor
28 Previous Clinical Trials
24,600 Total Patients Enrolled
22 Trials studying Breast Cancer
20,643 Patients Enrolled for Breast Cancer
ETOP IBCSG Partners FoundationLead Sponsor
65 Previous Clinical Trials
57,865 Total Patients Enrolled
30 Trials studying Breast Cancer
44,316 Patients Enrolled for Breast Cancer
Alliance for Clinical Trials in OncologyOTHER
512 Previous Clinical Trials
217,116 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer

Media Library

Endocrine therapy interruption Clinical Trial Eligibility Overview. Trial Name: NCT02308085 — N/A
Breast Cancer Research Study Groups: Endocrine therapy interruption
Breast Cancer Clinical Trial 2023: Endocrine therapy interruption Highlights & Side Effects. Trial Name: NCT02308085 — N/A
Endocrine therapy interruption 2023 Treatment Timeline for Medical Study. Trial Name: NCT02308085 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being actively recruited for this medical experiment?

"As reported on clinicaltrials.gov, this medical study has concluded its recruitment phase and is no longer taking applications. Initially posted in December 2014 with a final update made in August 2022, this trial has been superseded by the other 2290 trials currently recruiting participants."

Answered by AI

Is it feasible for me to register in this clinical trial?

"This clinical trial, which is enrolling 518 individuals afflicted with breast cancer between 18 and 42 years of age, mandates that participants have only recently stopped adjuvant endocrine therapy (SERM alone, GnRH analogue plus SERM or AI) for a period of 18-30 months. Moreover, those wishing to become pregnant are eligible as well as patients who underwent oocyte/embryo/ovarian tissue cryopreservation at the time of diagnosis or received pharmaco-prevention. Lastly, neo/adjuvant chemotherapy and other systemic therapies may have been administered according to institutional policy and patient preference."

Answered by AI

In what locations can this research be accessed?

"Potential participants of this study can find a trial site at Sanford Clinic North - Bemidji in Minnesota, Bozeman Deaconess Hospital in Montana, and the Roger Maris Cancer Centre in Fargo. Additionally, there are over 100 other medical locations involved as well."

Answered by AI

Is this investigative research open to individuals 80 years of age or older?

"This medical trial is limited to patients aged 18-42. While there are 64 other trials for minors, 2208 studies exist that enroll individuals over the age of 65."

Answered by AI
Recent research and studies
~79 spots leftby Dec 2025