Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516289
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib Camrelizumab
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib HRS-1167 Famitinib and Camrelizumab A Prospective Open-label Multicenter Phase II Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective open-label multi-center phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene gBRCA12 that were indicated for neoadjuvant chemotherapy The characteristics of this study are a precision treatment scheme without chemotherapy the scheme of HRS-1167 combined with famitinib neoadjuvant therapy for patients with gBRCA mutations is explored and the efficacy of combined immunotherapy is further explored according to the efficacy of the combination of the two drugs
Detailed Description:
This study is a prospective open-label multi-center phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene gBRCA12 that were indicated for neoadjuvant chemotherapy The characteristics of this study are a precision treatment scheme without chemotherapy the scheme of HRS-1167 combined with famitinib neoadjuvant therapy for patients with gBRCA mutations is explored and the efficacy of combined immunotherapy is further explored according to the efficacy of the combination of the two drugs The study consists of a safety run-in period to explore the safety of HRS-1167 combined with famitinib which is used to provide a recommended dose for the combination of HRS-1167 and famitinib The latter phase II period is used to explore the efficacy of HRS-1167 plus famitinib HRS-1167 plus famitinib plus camrelizumab as neoadjuvant therapy for gBRCA-mutated HER2-negative breast cancer The primary endpoints in safety run-in period the incidence of dose-limiting toxicity DLT the incidence and severity of adverse events AE and serious adverse events SAE in phase 2 the rate of pathological complete response pCR after surgery for each cohort as assessed by the investigator Secondary endpoints included residual cancer burden RCB score 3-year event-free survival EFS objective response rate ORR complete cell cycle arrest CCCA rate for HRHER2 - breast cancer safety and translational exploration study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None