TerminatedPhase 1/2

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

Stopped: insufficient recruitment

France2 participantsStarted 2024-04-05

Plain-language 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. 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Tumor-infiltrating lymphocytes (TILs) ≥ 30%, as defined by the International TILs Working Group 2014.
✓. ctDNA dosing at baseline.

Exclusion criteria

What they're measuring

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

Timeframe: 9 months

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

Timeframe: 9 months

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

Timeframe: 30 months

Trial details

NCT IDNCT06067061

SponsorInstitut Curie

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-07

View on ClinicalTrials.gov More Triple Negative Breast Neoplasms trials

Plain-language summary

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓. Tumor-infiltrating lymphocytes (TILs) ≥ 30%, as defined by the International TILs Working Group 2014.
✓. ctDNA dosing at baseline.

Exclusion criteria

What they're measuring

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

Timeframe: 9 months

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

Timeframe: 9 months

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

Timeframe: 30 months