Clinical Trial: NCT03802604
Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer
Status:
COMPLETEDPhase:
Early Phase 1| Lead Sponsor: | SOLTI Breast Cancer Research Group |
| Information Provided By: | SOLTI Breast Cancer Research Group |
| Last Update Posted: | 2025-09-09 |
Study Overview
Brief Summary
PROMETEO is a window opportunity, single arm, exploratory study to evaluate the effect of T- VEC combined with Atezolizumab in women with operable early breast cancer who present residual disease after Neoadjuvant Chemotherapy (NAC). Other eligibility criteria include TNBC or LumB like primary tumor sized at least 1.5 cm, ECOG PS 0-1 and evaluable diagnostic tumor sample.
Official Title
Combination of Talimogene Laherparepvec With Atezolizumab in Patients With Residual Breast Cancer After Standard Neoadjuvant Multi-agent Chemotherapy (PROMETEO TRIAL)
Conditions
Breast Cancer
Intervention / Treatment
- Biological: Talimogene laherparepvec
- Drug: Atezolizumab
Other Study ID Numbers
- SOLTI-1503
- 2018-001300-10
- 2018
Start Date (Actual)
2018-12-10
Primary Completion Date (Actual)
2022-04-27
Study Completion Date (Actual)
2025-03-18
Enrollment (Actual)
28
Study Type
Interventional
Phase
Early Phase 1
| Lead Sponsor: | SOLTI Breast Cancer Research Group |
| Information Provided By: | SOLTI Breast Cancer Research Group |
| Last Update Posted: | 2025-09-09 |
Study Overview
Brief Summary
PROMETEO is a window opportunity, single arm, exploratory study to evaluate the effect of T- VEC combined with Atezolizumab in women with operable early breast cancer who present residual disease after Neoadjuvant Chemotherapy (NAC). Other eligibility criteria include TNBC or LumB like primary tumor sized at least 1.5 cm, ECOG PS 0-1 and evaluable diagnostic tumor sample.
Official Title
Combination of Talimogene Laherparepvec With Atezolizumab in Patients With Residual Breast Cancer After Standard Neoadjuvant Multi-agent Chemotherapy (PROMETEO TRIAL)
Conditions
Breast Cancer
Intervention / Treatment
- Biological: Talimogene laherparepvec
- Drug: Atezolizumab
Other Study ID Numbers
- SOLTI-1503
- 2018-001300-10
- 2018
Start Date (Actual)
2018-12-10
Primary Completion Date (Actual)
2022-04-27
Study Completion Date (Actual)
2025-03-18
Enrollment (Actual)
28
Study Type
Interventional
Phase
Early Phase 1