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New genetic counseling method may help breast cancer patients decide on surgery

NCT ID NCT04245176

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a special, graph-based genetic counseling method helps newly diagnosed breast cancer patients better understand their risk of cancer in the other breast and make more informed surgery choices. About 400 patients participated, comparing this new approach to standard genetic counseling. The goal was to see if it changed their risk perception and surgical decisions.

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

400 people

The number who actually took part.

Started

Jan 2020

Finished

Jan 2026

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 to 79 years

Sex

Anyone

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 * Patients with a new breast cancer diagnosis (invasive or in-situ) considering genetic testing * Patients with good understanding of written and spoken English * Patients with apparent cognitive capacity to make surgical decisions for themselves * Patients who are medically cleared for surgery * Patients must be at least age 18 but under 79 Exclusion Criteria * Previous breast cancer diagnosis (invasive or DCIS) * Metastatic breast cancer * Patients who have received prior broad-based panel testing (prior BRCA1/2 testing with negative results allowed) * Bilateral breast cancer * Known medical or surgical contraindication to contralateral mastectomy * Hematologic malignancy necessitating skin biopsy/fibroblast culture for germline genetic testing malignancy other than cervical cis or basal or squamous cell skin cancers.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma in situ breast neoplasm invasive breast carcinoma

As listed by the trial registrant

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

Breast cancer Genetic testing In situ breast cancer Invasive breast cancer

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.