New tool helps breast cancer patients decide on preventive breast removal

NCT ID NCT02918474

Knowledge-focused Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a decision-making tool for women newly diagnosed with early-stage breast cancer who are considering removing the healthy breast as a preventive measure. The tool aims to improve knowledge and reduce uncertainty about the choice. Only 15 participants are enrolled, and the focus is on whether the tool is helpful and clear, not on medical outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Decision aid tool
What this could lead to: If it works, this tool could help breast cancer patients make more informed, less conflicted decisions about preventive breast removal.
What could go wrong: This is a very small study (15 people) testing only the tool's acceptability and knowledge impact, not its long-term outcomes. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2017

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadic unilateral invasive breast cancer * Able to speak read or write English Exclusion Criteria: * Patients with previous breast cancer * Prior history of bilateral prophylactic mastectomy * Known to have a germline mutation that predisposes them to an increased risk of breast cancer (e.g. BRCA1/2) and/or they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Anatomic stage I breast cancer ajcc V8 are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer ductal breast carcinoma in situ invasive breast carcinoma sporadic breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New tool helps breast cancer patients decide on preventive breast removal

What the study statuses mean