Ignite Creation Date:
2024-05-06 @ 1:19 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03988036
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2019-03-07
Brief Title:
A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype Keyriched-1
Sponsor:
West German Study Group
Organization:
West German Study Group
Study Overview
Official Title:
A Prospective Multicenter Open Label Neoadjuvant Phase II Single Arm Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype
Status:
COMPLETED
Status Verified Date:
2023-05
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:
Keyriched-1
Brief Summary:
Keyriched-1 is a multicenter interventional prospective single arm open label neoadjuvant phase II trial evaluating the pathological complete response pCR rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50
Detailed Description:
HER2-positive breast cancer is best defined by multiparameter gene expression profiling rather than analysis of the overexpressionamplification status of only HER2 As this subgroup is often correlated with a high expression of TILs and PDPD-L1 immunogenic therapy strategies seem very promising The pCR highly correlates with the overall outcome of patients with HER2-positive breast cancer 7 Therefore the pCR rate after neoadjuvant treatment has been adopted as a surrogate endpoint and more recently as a basis for accelerated drug approval 38
Due to the high number of patients achieving a pCR after standard treatment of anti-HER2 therapy combined with chemotherapy de-escalated strategies seem promising and designing a chemotherapy-free trial regimen is therefore modern justifiable and of high scientific value Therefore we designed a prospective phase II single arm hypothesis-generating trial investigating the rate of pCR in patients with HER2-enriched breast cancer receiving four cycles of dual anti-HER2 blockade in combination with the checkpoint inhibitor pembrolizumab Further translational research will be added to gain further insight into the tumor response or resistance to this treatment approach The addition of standard chemotherapy after this study treatment will be at the discretion of the investigator In case of a non-pCR after study treatment continuing treatment with chemotherapy and antihormonal therapy in case of HR positive disease is highly recommended
Due to the high number of patients achieving a pCR after standard treatment of anti-HER2 therapy combined with chemotherapy de-escalated strategies seem promising and designing a chemotherapy-free trial regimen is therefore modern justifiable and of high scientific value Therefore we designed a prospective phase II single arm hypothesis-generating trial investigating the rate of pCR in patients with HER2-enriched breast cancer receiving four cycles of dual anti-HER2 blockade in combination with the checkpoint inhibitor pembrolizumab Further translational research will be added to gain further insight into the tumor response or resistance to this treatment approach The addition of standard chemotherapy after this study treatment will be at the discretion of the investigator In case of a non-pCR after study treatment continuing treatment with chemotherapy and antihormonal therapy in case of HR positive disease is highly recommended
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-003996-37 | EUDRACT_NUMBER | None | None |