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Promising drug cocktail aims to control aggressive breast cancer

NCT ID NCT06690840

Disease control Sponsor: European Institute of Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a combination of three drugs (atezolizumab, vinorelbine, and cyclophosphamide) in people with advanced triple-negative breast cancer that has spread. Participants have already received immunotherapy before. The goal is to see if this new mix can shrink tumors or slow the disease. About 45 people will take part.

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

About 45 people

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

Started

Mar 2025

Expected to finish

Feb 2027

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: * Signed Informed Consent Form * Patients with locally advanced or metastatic, histologically documented TNBC (absence of human epidermal growth factor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PR\] expression) PD-L1+ (Immune Cell \>1% using Ventana SP142 assay), not amenable to surgical therapy * Locally advanced or metastatic TNBC, who have received an anti-PD-1/PD-L1 containing regimen in the neoadjuvant/adjuvant setting * No prior chemotherapy or targeted systemic therapy (including endocrine therapy) or immunotherapy for inoperable locally advanced or metastatic TNBC * Tissue accessible for biopsies * Expected survival of \> 3 months * Female or male subject ≥18 years * Have measurable/evaluable metastatic disease (RECIST 1.1 criteria) * Performance status 0-1 on Eastern Cooperative Oncology Group Performance Status (ECOG PS) * Demonstrate adequate organ (kidney, liver) function Exclusion Criteria: * Patients with de novo metastatic TNBC OR those who have received 1 or more chemotherapy or targeted systemic therapy (including endocrine therapy) or immunotherapy regimens for advanced disease * Immunodeficiency or systemic steroid therapy/immunosuppressive therapy within 7 days prior to study entry * Known history of active Bacillus Tuberculosis (TBC) * Hypersensitivity to anti- PD-L1 antibodies or its excipients * Active autoimmune disease * Known history of non-infectious pneumonitis * Active infection requiring systemic therapy * Known history of Human Immunodeficiency Virus (HIV) * Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\]) * Live vaccine within 30 days * Bone or brain metastases

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Conditions

The condition(s) this trial relates to.

breast neoplasm 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

How to take part

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

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Azienda Sanitaria Locale Br

    NOT_YET_RECRUITING

    Brindisi, Italy

  • European Institute of Oncology

    RECRUITING

    Milan, 20141, Italy

  • Fondazione IRCCS San Gerardo Dei Tintori

    RECRUITING

    Monza, Monza, 20900, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    NOT_YET_RECRUITING

    Roma, Roma, 00168, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    NOT_YET_RECRUITING

    Roma, Roma, 00168, Italy

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