AzTrials
AzTrials

Breast CancerPhase 2ATREZZONCT04759248

Study With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer

A Phase 2 study testing Atezolizumab + Trastuzumab + Vinorelbine in people with Breast Cancer, run by SOLTI Breast Cancer Research Group at 15 sites in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Immune checkpoint inhibitors given in monotherapy in advanced breast cancer have shown modest benefit in first-line, but very limited efficacy in later lines. Thus, combination therapies are needed. Response following anti-PD1/PD-L1 monotherapy is associated with large survival benefit in the advanced setting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Atezolizumab + Trastuzumab + Vinorelbine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
15 sitesSpain
Study dates
15 Mar 2021to 1 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Spain15 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, La Coruña, 15006

  • Hospital General Universitario de Alicante

    Alicante

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Hospital Clinic de Barcelona

    Barcelona

  • Hospital Universitari Vall d' Hebron

    Barcelona

  • Hospital San Pedro de Alcántara

    Cáceres

  • H. Clínico San Cecilio de Granada

    Granada, Andalusia

  • Institut Català d'Oncologia Hospitalet

    L'Hospitalet de Llobregat, Barcelona

  • Hospital de León

    León, 24071

  • Hospital Universitario 12 de octubre

    Madrid

  • Hospital Son Espases

    Palma de Mallorca

  • Hospital Universitari Sant Joan de Reus

    Reus, 43201

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, Canary Islands, 38320

  • Hospital Universitario Virgen del Rocio

    Seville

  • Hospital Clinico Universitario de Valencia

    Valencia

Other trials in Spain

About this study

Official title: A Phase II With 2 Parallel Cohorts Clinical Trial Targeting Estrogen Receptor Negative or PAM50 Non-luminal Disease With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer - ATREZZO Study

Immune checkpoint inhibitors given in monotherapy in advanced breast cancer have shown modest benefit in first-line, but very limited efficacy in later lines. Thus, combination therapies are needed.

Response following anti-PD1/PD-L1 monotherapy is associated with large survival benefit in the advanced setting.

Read more

Previous studies of the intrinsic subtypes have shown that Basal-like and HER2-E are associated with higher expression of immune-related genes or higher infiltration of stromal tumor infiltrating lymphocytes compared to the luminal subtypes. Immune infiltration in BC is associated with chemo/antiHER2 responsiveness and potentially benefit from anti-PD-1/PD-L1 inhibitors.

In addition, one emerging biomarker of response to anti-PD-1 therapy is the tumor mutational burden (I.e. the total number of mutations per coding area of a tumor genome). The HER2-E and Basal-like profiles have been associated with high mutational burden.

A range of studies have been initiated including several phase II/III studies evaluating atezolizumab in combination with different chemotherapeutic compounds routinely used in breast cancer, but none with predefined biomarker beyond the expression of PD-L1 by IHC

Conditions
Breast Cancer
Being tested
Atezolizumab + Trastuzumab + Vinorelbine
Keywords
cancer, breast cancer
Medical subject headings
Breast Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atezolizumab + Trastuzumab + VinorelbineDrug

    • Atezolizumab IV 1200 mg in combination with
    • Trastuzumab sc 600mg or IV 6mg/kg every 3 weeks and
    • Vinorelbine 25 mg/m² IV or 60 mg/m2 PO on days 1 and 8, every 3 weeks during the first cycle and if there are no toxicity signs dose will be increased to 80 mg/m2 PO o 30 mg/m2 IV.
Study groups in NCT04759248
Study groupRoleWhat they receive
Atezolizumab in combination with Trastuzumab and VinorelbineExperimentalNot described
Receives: Drug: Atezolizumab + Trastuzumab + Vinorelbine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response rate

    the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

    Measured: until disease progression or up to 2 years after treatment ends

Secondary outcomes (11)

  1. Overall Response rate in PD-L1+ patients

    the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

    Measured: until disease progression or up to 2 years after treatment ends

  2. Clinical Benefit

    Clinical Benefit Rate at 24 weeks

    Measured: 24 weeks

  3. Overal survival

    Time from the date of allocation to the date of death due to any cause.

    Measured: Until analysis data cutoff, 2 years

  4. Progression free survival

    Survival witouth observed progression

    Measured: 24 weeks

  5. Duration of response

    time from first documented response until progression

    Measured: 24 weeks

  6. Time to response

    time until first documented response

    Measured: 24 weeks

  7. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    AEs according to CTCAE v 5.0.

    Measured: until end of treatment / through study completion, an average of 1 year

  8. Overall Response rate in patients with brain metastases at baseline

    Patients with a history of brain metastases, current brain metastases, or equivocal brain lesions at baseline

    Measured: Until disease progression or up to 2 years after treatment ends

  9. Clinical Benefit in patients with brain metastases at baseline

    Clinical Benefit Rate at 24 weeks in patients with a history of brain metastases, current brain metastases, or equivocal brain lesions at baseline

    Measured: 24 weeks

  10. Progression free survival in patients with brain metastases at baseline

    Survival without observed progression in patients with a history of brain metastases, current brain metastases, or equivocal brain lesions at baseline

    Measured: 24 weeks

  11. Overal survival in patients with brain metastases at baseline

    Time from the date of allocation to the date of death due to any cause.

    Measured: Until analysis data cutoff, 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2021
  2. Study start15 Mar 2021
  3. Primary completion1 Dec 2024
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is an open-label, single arm, Simon 2-stage, multicenter phase II study evaluating treatment with atezolizumab in combination with trastuzumab and vinorelbine in patients with locally advanced or metastatic PAM50 non-luminal/HER2+ BC refractory to trastuzumab based therapy and anti-HER2 ADC treatment.
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04759248
Sponsor's protocol ID
SOLTI-1907
Other IDs
2020-000245-13
Acronym
ATREZZO
Status last verified
Sep 2025
First submitted
28 Jan 2021
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab + Trastuzumab + Vinorelbine in people with Breast Cancer, run by SOLTI Breast Cancer Research Group at 15 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response rate (time frame: until disease progression or up to 2 years after treatment ends). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04759248.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in