Informations générales (source: ClinicalTrials.gov)
"neoBREASTIM": A Phase 2 Study of Atezolizumab Plus RP1 Oncolytic Immunotherapy in the NeoAdjuvant Setting of Triple-Negative Breast Cancer (TNBC) (neoBREASTIM)
Interventional
Phase 1/Phase 2
Institut Curie (Voir sur ClinicalTrials)
avril 2024
avril 2031
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:39 | Contacter | |||
Critères
Femme
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.
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.
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.