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New study maps how Triple-Negative breast cancer is treated outside the US

NCT ID NCT07092254

Knowledge-focused Sponsor: Daiichi Sankyo 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This observational study tracks how doctors treat advanced triple-negative breast cancer in Canada, the UK, France, and Spain. Researchers will look at real-world data from 760 patients to understand treatment patterns and outcomes. No new drugs are being tested—the goal is to gather information that may help improve future care.

What this could mean

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

What this could lead to
If successful, this study could help doctors understand how triple-negative breast cancer is currently treated outside the US and improve future treatment guidelines.
What could go wrong
This is an observational study, not a treatment trial. It collects data only and does not test any new drug or therapy, so it cannot directly improve patient outcomes.

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.

Participants

About 760 people

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

Started

Sep 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The study population will consist of adult patients residing in Canada, France, Spain, and the United Kingdom who received a diagnosis of hormone receptor (HR)-negative and HER2-negative advanced/metastatic TNBC any time from 1 January 2020 to 31 March 2024.

Ages

18 years and older

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.

Patients meeting the following criteria will be included in the study: * Histologically or cytologically documented diagnosis of HR-negative and HER2-negative locally recurrent inoperable TNBC (i.e., cannot be treated with curative intent) or advanced/metastatic TNBC from 1 January 2020 to 31 March 2024 * Negative for estrogen receptor with \< 1% of tumor cells positive for estrogen receptor (ER) on immunohistochemistry (IHC) * Negative for progesterone receptor with \< 1% of tumor cells positive for progesterone receptor on IHC * Negative for HER2 with 0 or 1+ intensity on IHC or 2+ intensity on IHC and negative by in situ hybridization per the American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) HER2 guideline * The test documented closest to the diagnosis date should be used as the reference * Aged at least 18 years upon diagnosis of advanced/metastatic TNBC * Known vital status (alive or deceased) as of last available follow-up date documented within the medical record Patients meeting any of the following exclusion criteria will not be eligible for the study: * Diagnosis of other prior primary cancers or malignancies (except nonmelanoma skin cancer) unless curatively treated with no evidence of disease for at least 3 years before diagnosis of advanced/metastatic TNBC * Ever received treatment as part of any clinical trial of an investigational product for cancer * No available medical record entry in the 90 days before or after diagnosis of advanced/metastatic TNBC

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

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

Triple-negative breast cancer

Contacts and locations

Locations

  • Research Site

    Basking Ridge, New Jersey, 07920, United States

More trials for these conditions

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