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New drug cocktail targets hard-to-treat breast cancer

NCT ID NCT04759248

Disease control Sponsor: SOLTI Breast Cancer Research Group 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial is testing a combination of three drugs—atezolizumab, trastuzumab, and vinorelbine—in people with HER2-positive advanced or metastatic breast cancer that has already been treated with trastuzumab and other anti-HER2 therapies. The study focuses on patients whose tumors are estrogen receptor negative or have a non-luminal genetic profile, which may be more responsive to immunotherapy. The main goal is to see how many patients have their tumors shrink or disappear.

What this could mean

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

Active substance
atezolizumab, trastuzumab, and vinorelbine
What this could lead to
If successful, this combination could offer a new treatment option for people with HER2-positive advanced breast cancer that has not responded to standard therapies.
What could go wrong
This is a small phase 2 trial with only 55 participants, so results may not apply to everyone. The drugs can cause side effects like immune reactions, nerve damage, and low blood 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

About 55 people

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

Started

Mar 2021

Expected to finish

Jul 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: * Male or female (Premenopausal or postmenopausal women) * ECOG 0 to 2 * Histologically confirmed adenocarcinoma of the breast, metastatic or unresectable locally advanced. * All patients must have received at least trastuzumab and other anti-HER2 ADCs (including but not limited to T-DM1). * Measurable disease according to RECIST 1.1 criteria. * Adequate organ function * Baseline LVEF ≥50% * Participants with asymptomatic brain metastases are eligible. Exclusion Criteria: * Treatment with any investigational anticancer drug within 14 days of the start of study treatment. * Patient has received Vinorelbine or any other vinca alkaloids previously immediately prior to initiate study treatment. * History of other malignant tumors in the past 3 years * Known or suspected leptomeningeal disease (LMD)/ poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain metastases. * Symptomatic hypercalcemia requiring treatment with bisphosphonates in the 14 days prior to inclusion * Cardiopulmonary dysfunction * Any other severe, uncontrolled * Major surgery in the 28 days prior to enrolment * Infection with HIV or active Hepatitis B and/or Hepatitis C. * History of trastuzumab intolerance, including grade 3-4 infusion reaction or hypersensitivity. * Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation * History of autoimmune disease, * Prior allogeneic stem cell or solid organ transplantation * History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan. (Note: History of radiation pneumonitis in the radiation field \[fibrosis\] is permitted.) * Active tuberculosis * Receipt of a live, attenuated vaccine within 4 weeks prior to enrollment * Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1 therapeutic antibody or immune checkpoint targeting agents * Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin \[IL\]-2) within 4 weeks or five half-lives of the drug prior to enrolment * Treatment with systemic immunosuppressive medications within 2 weeks prior to enrolment, or anticipated requirement for systemic immunosuppressive medications during the trial.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma neoplasm

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, La Coruña, 15006, Spain

  • H. Clínico San Cecilio de Granada

    Granada, Andalusia, Spain

  • Hospital Clinic de Barcelona

    Barcelona, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, Spain

  • Hospital General Universitario de Alicante

    Alicante, Spain

  • Hospital San Pedro de Alcántara

    Cáceres, Spain

  • Hospital Son Espases

    Palma de Mallorca, Spain

  • Hospital Universitari Sant Joan de Reus

    Reus, 43201, Spain

  • Hospital Universitari Vall d' Hebron

    Barcelona, Spain

  • Hospital Universitario 12 de octubre

    Madrid, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Spain

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, Canary Islands, 38320, Spain

  • Hospital de León

    León, 24071, Spain

  • Hospital del Mar

    Barcelona, Barcelona, 08003, Spain

  • Institut Català d'Oncologia Hospitalet

    L'Hospitalet de Llobregat, Barcelona, Spain

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