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Triple Negative Breast NeoplasmsPhase 1/2neoBREASTIMNCT06067061

"neoBREASTIM": Atezolizumab Plus RP1 Oncolytic Immunotherapy in the NeoAdjuvant Setting of Triple-Negative Breast Cancer

A Phase 1/2 study testing Atezolizumab + RP1 in people with Triple Negative Breast Neoplasms, run by Institut Curie at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Neoadjuvant treatment is an important part of the treatment strategy for locally advanced TNBC having established a positive and significant correlation of pathologic Complete Response (pCR) with long-term clinical benefit such as Event-Free Survival (EFS) and Overall Survival (OS) as shown via large meta-analysis. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Triple Negative Breast Neoplasms
What is being tested?
Atezolizumab + RP1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteFrance
Study dates
5 Apr 2024to 7 May 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female subject
  • Age ≥ 18 years old.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1.
  • Newly diagnosed Triple-Negative Breast Cancer (TNBC), defined as the absence of estrogen expression and progesterone expression, and of Human Epidermal growth factor Receptor 2 (HER2) overexpression, must be determined by local testing of a screening tumor sample as defined by American Society of Clinical Oncology/College of American Pathologists guidelines.
  • TNBC defined as the following combined primary tumor (T), regional lymph node (N), and metastatic (M) American Joint Committee on Cancer staging criteria: cT ≥15 - ≤30 mm, N0, M0 according to Mammogram, breast Ultrasound and MRI, and PET-CT. In case of a difference in the measurement of the primary tumor among different imaging methods, the breast MRI measurement is the reference.
  • Unicentric, unifocal and unilateral disease.
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  • Tumor-infiltrating lymphocytes (TILs) ≥ 30%, as defined by the International TILs Working Group 2014.
  • ctDNA dosing at baseline.
  • Agreement to provide tissue samples (tumor biopsy at screening and on-treatment), and at surgery for immune monitoring and translational research activities.
  • Agreement to perform blood samples at screening, on-treatment, and at surgery for immune monitoring and translational research activities.

Who cannot join

  • Inflammatory breast cancer.
  • Prior treatment with an oncolytic virus-based therapy.
  • Patients with active significant herpetic infections or prior complications of Herpes Simplex Virus-1 (HSV-1) infection.
  • Patients who require intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (e.g., acyclovir).
  • Diagnosis of immunodeficiency.
  • Has active autoimmune disease (e.g. inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, and multiple sclerosis, celiac disease, Wegener's granulomatosis) that has required systemic treatment in the past 3 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
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  • Prior systemic immunosuppressive medication (except physiologic corticosteroid replacement therapy) within 30 days of planned start of study therapy.
  • Any live (attenuated) vaccine within 14 days of planned start of study therapy.
  • Prior immunotherapy, including tumor vaccine, cytokine, anti-CTLA4, PD-1/PD-L1 blockade or similar agents, T cell receptor-based (TCR-based) or Chimeric Antigen Receptor-T (CAR-T) cell based adoptive cell therapy.
  • Known history of, or any evidence of active, non-infectious pneumonitis.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Curie

    Paris, 75005

Other trials in France

About this study

Official title: "neoBREASTIM": A Phase 2 Study of Atezolizumab Plus RP1 Oncolytic Immunotherapy in the NeoAdjuvant Setting of Triple-Negative Breast Cancer (TNBC)

Neoadjuvant treatment is an important part of the treatment strategy for locally advanced TNBC having established a positive and significant correlation of pathologic Complete Response (pCR) with long-term clinical benefit such as Event-Free Survival (EFS) and Overall Survival (OS) as shown via large meta-analysis. Much effort has been made to identify novel agents and new drug combinations that can improve pCR rates in this specific clinical setting, which is the leading rationale to evaluate RP1 oncolytic immunotherapy in combination with Atezolizumab.

Read the detailed description

The combination of RP1 plus Atezolizumab, while being expected to result in increased efficacy, is not expected to result in significant additional toxicity, as compared to either agent alone. Capitalizing on the strong prognostic and predictive value of the TIL infiltrate in early-stage TNBC and the capacity of circulating tumor DeoxyriboNucleic Acid (ctDNA) detection to predict response to immunotherapy and NeoAdjuvant Chemotherapy (NAC), neoBREASTIM - a single-arm phase 2 study - will evaluate a novel, biomarker-driven combination of Atezolizumab plus RP1 oncolytic immunotherapy in the neo-adjuvant setting of patients diagnosed with early-stage, TIL-high TNBC.

Being tested
Atezolizumab + RP1
Keywords
Triple Negative Breast Cancer, Early-stage, Immunotherapy, Oncolytic virus
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

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

  • Atezolizumab + RP1Combination product

    Also called Tecentriq®, Vusolimogene Oderparepvec

    Patients will be treated in a window period (ie 3 treatment cycles). After evaluation, patients that had no increase in ctDNA after 3 cycles (see Definition of ctDNA status) will continue on the same treatment (intratumoral injections of RP1 in combination with Atezolizumab) for a total of 10 treatment cycles prior to surgery.

Study groups in NCT06067061
Study groupRoleWhat they receive
Atezolizumab plus RP1 (Immulytic™) oncolytic immunotherapyExperimentalAtezolizumab IV q2w RP1 (Immulytic™) by imaging-guided intra-tumor (IT) route.
Receives: Combination Product: Atezolizumab + RP1

What is being measured

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

  1. Safety of the combination Atezolizumab plus RP1 oncolytic during the safety run-in phase

    Incidence of combination Atezolizumab plus RP1 adverse events (AEs) graded according to NCI CTCAE v5.0 and nature and severity

    Measured: 9 months

  2. Toxicity of the combination Atezolizumab plus RP1 oncolytic immunotherapy during the safety run-in phase.

    Dose Limiting Toxicity (DLT) during the first cycle of treatment of the combination Atezolizumab plus RP1 oncolytic immunotherapy

    Measured: 9 months

  3. Residual Cancer Burden (RCB) 0-1 during the phase II part

    Rate of RCB 0-1 at time of surgery (in patients with no increase in ctDNA after cycle 3)

    Measured: 30 months

Secondary outcomes (9)

  1. Response rate of RCB Score <= 1 at three cycles

    Rate of RCB 0-1 after cycle 3 (in patients with no increase in ctDNA after cycle 3)

    Measured: 26 months

  2. Safety and toxicity of the combination Atezolizumab plus RP1 oncolytic immunotherapy

    Incidence, nature and severity of adverse events (AEs) graded according to NCI CTCAE v5.0 from the treatment start to the surgery

    Measured: 60 months

  3. Invasive disease-free survival (iDFS)

    iDFS will be measured using regular follow-up visits

    Measured: 60 months

  4. Percentage of TILs

    The percentage of TILs will be estimated and compared between RCB rates 0-1 versus 2-3

    Measured: 30 months

  5. Pre-treatment expression of Programmed Death-Ligand 1 (PD-L1)

    Expression of PD-L1 will be estimated and compared between RCB rates 0-1 versus 2-3

    Measured: 30 months

  6. Correlation between RCB rates and response by Positron Emission Tomography-Scan (PET-CT) or breast MRI

    To correlate the response by RCB rates with response by PET-CT or breast MRI will be studied

    Measured: 60 months

  7. RCB rates and response

    To correlate the response by breast MRI with RCB 0-1 rates,

    Measured: 60 months

  8. Breast Conservation Surgery (BCS)

    The rate of Breast Conservation Surgery (BCS) will be presented

    Measured: 30 months

  9. Correlation between RCB rates and radiomics analyses

    To correlate the RCB rates with response by radiomics analyses.

    Measured: 30 months

Timeline

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

  1. First posted4 Oct 2023
  2. Study start5 Apr 2024
  3. Primary completion7 May 2025
  4. Study completion7 May 2025

Why it stopped: insufficient recruitment

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
An open-label, monocentric, single arm, phase II study with a safety run-in.
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06067061
Sponsor's protocol ID
IC 2021-10
Other IDs
2022-502311-12-00
Acronym
neoBREASTIM
Status last verified
Jun 2025
First submitted
25 Sep 2023
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Atezolizumab + RP1 in people with Triple Negative Breast Neoplasms, run by Institut Curie at 1 site in France.

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 10 inclusion and 10 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: stopped early, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.

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?

Safety of the combination Atezolizumab plus RP1 oncolytic during the safety run-in phase (time frame: 9 months). The study lists 3 primary outcomes in all. 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 NCT06067061.

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 11 Jun 2025.

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