NCT06067061: neoBREASTIM

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

Terminated Phase 1, PHASE2 Last updated 11 June 2025

What this trial tests

Phase 1, PHASE2 trial testing Atezolizumab + RP1 in Triple Negative Breast Neoplasms in 2 participants. Terminated before completion.

Timeline

5 April 2024

Primary endpoint
7 May 2025

7 May 2025

Quick facts

Lead sponsor	Institut Curie
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	5 April 2024
Primary completion	7 May 2025
Estimated completion	7 May 2025
Sites	1 location across France

Drugs / interventions tested

• Atezolizumab + RP1

Conditions studied

• Triple Negative Breast Neoplasms — all drugs for Triple Negative Breast Neoplasms →

Sponsor

Institut Curie — full company profile →

Who can join

18 and older, female only, with Triple Negative Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current trends in sensitizing immune checkpoint inhibitors for cancer treatment.
   Wei J, Li W, Zhang P, Guo F, et al · · 2024 · cited 82× · PMID 39725966 · DOI 10.1186/s12943-024-02179-5
2. Clinico-pathological factors predicting pathological response in early triple-negative breast cancer.
   Helal C, Djerroudi L, Ramtohul T, Laas E, et al · · 2025 · cited 15× · PMID 39948122 · DOI 10.1038/s41523-025-00729-8
3. Recent Advances in Immune Checkpoint Inhibitors for Triple-Negative Breast Cancer.
   Corti C, Koca B, Rahman T, Mittendorf EA, et al · · 2025 · cited 11× · PMID 40196378 · DOI 10.2147/itt.s495751
4. Improving efficacy of TNBC immunotherapy: based on analysis and subtyping of immune microenvironment.
   Yang Y, Li H, Yang W, Shi Y. · · 2024 · cited 11× · PMID 39430759 · DOI 10.3389/fimmu.2024.1441667
5. Oncolytic HSV and cancer drug interactions: Current clinical status and future directions.
   Vázquez-Arreguín K, Rivera-Caraballo KA, Ventarapragada D, Chiocca EA, et al · · 2025 · cited 6× · PMID 40702727 · DOI 10.1016/j.ymthe.2025.07.034
6. Recent advances in oncolytic virus combined immunotherapy in tumor treatment.
   Zhou X, Hu S, Wang X. · · 2025 · cited 4× · PMID 40821119 · DOI 10.1016/j.gendis.2025.101599
7. Liquid biopsy in breast cancer: Redefining precision medicine.
   Schiavone ML, Scarpitta R, Ravera F, Bleve S, et al · · 2025 · cited 3× · PMID 40740670 · DOI 10.1016/j.jlb.2025.100312
8. Liquid biopsy for guiding breast cancer immunotherapy.
   Fina E, Vitale E, De Summa S, Gadaleta-Caldarola G, et al · · 2025 · cited 3× · PMID 40083311 · DOI 10.1080/1750743x.2025.2479426