Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-01 @ 5:00 PM
Study NCT ID:
NCT03802604
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2018-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Talimogene Laherparepvec With Atezolizumab in Early Breast Cancer
Sponsor:
SOLTI Breast Cancer Research Group
Organization:
Study Overview
Official Title:
Combination of Talimogene Laherparepvec With Atezolizumab in Patients With Residual Breast Cancer After Standard Neoadjuvant Multi-agent Chemotherapy (PROMETEO TRIAL)
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMETEO
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.
Detailed Description:
Primary objective:
• To evaluate the efficacy (as measured by residual cancer burden \[RCB\] class 0/1 rate) of Talimogene Laherparepvec with Atezolizumab given to subjects with operable early breast cancer who present residual disease after neoadjuvant chemotherapy (NAC).
Secondary objectives include:
* To assess the rate of pathological complete response (pCR) in the breast (pCRB) and breast and axilla (pCRBL) at definitive surgery after neoadjuvant treatment with T-VEC and atezolizumab.
* To determine the clinical and radiological ORR of breast tumors to TVEC- atezolizumab given in the neoadjuvant setting.
* To assess RCB index in continuous variable and by the 4 RCB class (RCB0, RCB1, RCB2 and RCB 3) after treatment with T-VEC and atezolizumab.
* Comparing the expression of a gene signature tracking activated CD8 T-cells at surgery after treatment with T-VEC and atezolizumab with residual disease after NAC.
* To evaluate the safety of T-VEC in combination with atezolizumab as assessed by incidence of treatment-emergent and treatment-related adverse events.
* Translational and exploratory objectives are included.
• To evaluate the efficacy (as measured by residual cancer burden \[RCB\] class 0/1 rate) of Talimogene Laherparepvec with Atezolizumab given to subjects with operable early breast cancer who present residual disease after neoadjuvant chemotherapy (NAC).
Secondary objectives include:
* To assess the rate of pathological complete response (pCR) in the breast (pCRB) and breast and axilla (pCRBL) at definitive surgery after neoadjuvant treatment with T-VEC and atezolizumab.
* To determine the clinical and radiological ORR of breast tumors to TVEC- atezolizumab given in the neoadjuvant setting.
* To assess RCB index in continuous variable and by the 4 RCB class (RCB0, RCB1, RCB2 and RCB 3) after treatment with T-VEC and atezolizumab.
* Comparing the expression of a gene signature tracking activated CD8 T-cells at surgery after treatment with T-VEC and atezolizumab with residual disease after NAC.
* To evaluate the safety of T-VEC in combination with atezolizumab as assessed by incidence of treatment-emergent and treatment-related adverse events.
* Translational and exploratory objectives are included.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-001300-10 | EUDRACT_NUMBER | None | View |