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Can tumor diversity predict chemotherapy success in Triple-Negative breast cancer?

NCT ID NCT03077776

Knowledge-focused Sponsor: UNICANCER 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study is looking at how triple-negative breast cancer evolves during chemotherapy. Researchers will take biopsies from the tumor before, during, and after treatment to see if the diversity of cancer cells affects how well the tumor responds. The goal is to understand why some tumors disappear completely with chemotherapy while others do not, which could help tailor treatment in the future.

What this could mean

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

Active substance
Biopsy procedure
What this could lead to
If successful, this could help doctors predict which patients with triple-negative breast cancer will respond to chemotherapy, potentially guiding more personalized treatment plans.
What could go wrong
This is an observational study, so it won't directly test a new treatment. The findings may not lead to immediate changes in care, and biopsies carry small risks like bleeding or infection.

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

149 people

The number who actually took part.

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

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: 1. Age 18-years or older 2. Patients with histological confirmation of invasive breast cancer with known receptor status suitable for neoadjuvant chemotherapy as assessed by the local investigator 3. Estrogen receptor (ER)- and progesterone receptor (PR)-negative as defined by ≤1% of positive staining on immunohistochemistry 4. Human epidermal growth factor receptor 2 (HER2)-negative as defined by American Society of Clinical Oncology / College of American Pathologists guidelines 5. T1c-4 tumours (including inflammatory cancers), with any nodal status non candidate for conservative surgery upfront. Bilateral or multifocal cancer is permitted provided that all sites are HER2-negative and at least one site is ER- and PR-negative. 6. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses 7. Patient with social insurance coverage Exclusion Criteria: 1. Confirmed metastatic disease at initial presentation 2. Any contraindication to the biopsy procedure 3. Previous or current malignancies of other origin within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin 4. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol 5. Individuals deprived of liberty or placed under the authority of a tutor

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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 neoplasm

Contacts and locations

Locations

  • Centre Eugène Marquis

    Rennes, France

  • Centre George François Leclerc

    Dijon, France

  • Centre Jean Perrin

    Clermont-Ferrand, France

  • Centre Leon Bérard

    Lyon, France

  • Centre Paul Strauss

    Strasbourg, France

  • Gustave Roussy

    Villejuif, France

  • Hopitaux universitaire de strasbourg - Hopital civil

    Strasbourg, France

  • Institut Paoli Calmettes

    Marseille, France

  • Institut de Cancerologie de l'Ouest

    Nantes, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, France