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Can a targeted drug help breast cancer patients with 'invisible' HER2?

NCT ID NCT01975142

Disease control Sponsor: Institut Curie 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 155 people with metastatic breast cancer whose original tumors were HER2-negative. Researchers checked their blood for HER2-positive cancer cells. Those who had them received the drug T-DM1, which delivers chemotherapy directly to HER2-positive cells. The goal was to see if the tumors would shrink.

What this could mean

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

Active substance
Trastuzumab-emtansine (T-DM1)
What this could lead to
If it works, this could offer a treatment option for people with metastatic breast cancer whose tumors test HER2-negative but have HER2-positive cells in their blood.
What could go wrong
This is a small, early-phase trial with no comparison group, so results may not apply widely. T-DM1 can cause side effects like liver damage and low blood cell counts.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

155 people

The number who actually took part.

Started

Nov 2013

Finished

Jan 2019

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 75 years

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: Inclusion criteria for screening: * Breast adenocarcinoma considered HER2-negative on the primary tumour or unknown status HER2 * A least one metastatic site and/or inoperable loco-regional relapse * Measurable disease (RECIST v1.1) * Age from 18 to 75 years * Performance status of 0-2 * Efficient contraceptive in non-menopause women Inclusion criteria for treatment : * At least 1 (Cohort " L ") or 3 (cohort " H ") HER2 amplified CTC * Performance status of 0-2 * Adequate cardiac function * Adequate hematological and biochemical blood tests Exclusion Criteria: * Life expectancy of less than 3 months * Previous history of any other stage III or IV invasive cancer * Male breast cancer * Uncontrolled brain metastases * Significant cumulated exposure to anthracyclines * Current or previous significant history of cardio-vascular/pulmonary disease * Previous use of trastuzumab

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Conditions

The condition(s) this trial relates to.

breast carcinoma breast neoplasm Her2-receptor negative breast cancer

As listed by the trial registrant

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

Metastatic breast cancer, HER2 negative primary tumor

Contacts and locations

Locations

  • Centre Catherine de Sienne

    Vandœuvre-lès-Nancy, 54519, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Centre Val d'Aurelle - P. Lamarque

    Montpellier, 34298, France

  • Chu Saint-Louis

    Paris, 75475, France

  • Chu de Limoges

    Limoges, 87042, France

  • Clinique Victor Hugo

    Le Mans, 72000, France

  • Institut Curie

    Paris, 75005, France

  • Institut Curie - Hôpital René HUGENIN

    Saint-Cloud, SAINT-CLOUD, France

  • Institut de Cancérologie HARTMANN

    Levallois-Perret, 92309, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

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