Combining Atezolizumab and RP1 for early-stage triple-negative breast cancer treatment

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

This study is testing if combining Atezolizumab and RP1 can help people with early-stage triple-negative breast cancer have better treatment results.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Institut Curie (Academic / other)
• Drugs / interventions: CAR-T, Chimeric Antigen Receptor, immunotherapy, Atezolizumab, Chemotherapy
• Locations: 1 site (Paris)
• Trial ID: NCT06067061 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a combination of Atezolizumab and RP1 oncolytic immunotherapy in patients with early-stage triple-negative breast cancer (TNBC). It focuses on patients with high levels of tumor-infiltrating lymphocytes (TILs) and aims to improve pathologic complete response rates, which are linked to better long-term outcomes. The study is designed as a single-arm phase 2 trial, leveraging biomarker-driven approaches to assess treatment response. The combination is expected to enhance efficacy without significantly increasing toxicity compared to using either agent alone.

Who should consider this trial

Good fit: Ideal candidates include females aged 18 and older with newly diagnosed, early-stage triple-negative breast cancer and high tumor-infiltrating lymphocytes.

Not a fit: Patients with non-triple-negative breast cancer or those with advanced metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved survival rates and better outcomes for patients with early-stage triple-negative breast cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in treating triple-negative breast cancer, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Female subject
2. Age ≥ 18 years old.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 1.
4. 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.
5. 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.
6. Unicentric, unifocal and unilateral disease.
7. Tumor-infiltrating lymphocytes (TILs) ≥ 30%, as defined by the International TILs Working Group 2014.
8. ctDNA dosing at baseline.
9. Agreement to provide tissue samples (tumor biopsy at screening and on-treatment), and at surgery for immune monitoring and translational research activities.
10. Agreement to perform blood samples at screening, on-treatment, and at surgery for immune monitoring and translational research activities.

Exclusion Criteria:

1. Inflammatory breast cancer.
2. Prior treatment with an oncolytic virus-based therapy.
3. Patients with active significant herpetic infections or prior complications of Herpes Simplex Virus-1 (HSV-1) infection.
4. Patients who require intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (e.g., acyclovir).
5. Diagnosis of immunodeficiency.
6. 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).
7. Prior systemic immunosuppressive medication (except physiologic corticosteroid replacement therapy) within 30 days of planned start of study therapy.
8. Any live (attenuated) vaccine within 14 days of planned start of study therapy.
9. 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.
10. Known history of, or any evidence of active, non-infectious pneumonitis.

Where this trial is running

Paris

• Institut Curie — Paris, France (Recruiting)

Study contacts

• Study coordinator: Emanuela ROMANO, MD

Conditions Triple Negative Breast Neoplasms; Triple Negative Breast Cancer; Early-stage; Immunotherapy; Oncolytic virus