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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

Age ≥ 18 and ≤ 42 years at enrollment

The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment

Must not have

Patients with previous or concomitant non-breast invasive malignancy

History of hysterectomy, bilateral oophorectomy or ovarian irradiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment until the first invasive bc event, assessed up to 14 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or had another type of cancer besides breast cancer.

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I have had a hysterectomy, both ovaries removed, or radiation to the ovaries.

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I was post-menopausal at the time of my breast cancer diagnosis.

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I have had breast cancer before, either in the same or the other breast.

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My breast cancer has returned or spread to other parts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment until the first invasive bc event, assessed up to 14 years

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.