Viewing Study NCT05726175



Ignite Creation Date: 2024-05-06 @ 6:36 PM
Last Modification Date: 2024-10-26 @ 2:51 PM
Study NCT ID: NCT05726175
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-02-13
First Post: 2023-01-30

Brief Title: Disitamab VedotinRC48 Combined With PenpulimabAK105 for Neoadjuvant Treatment of HER2-low Breast Cancer
Sponsor: West China Hospital
Organization: West China Hospital

Study Overview

Official Title: A Single-arm Single-center Exploratory Clinical Study of Disitamab Vedotin Combined With Penpulimab as Neoadjuvant Therapy in the Treatment of HER2-low Early or Locally Advanced Breast Cancer
Status: NOT_YET_RECRUITING
Status Verified Date: 2023-02
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: None
Brief Summary: To evaluate the efficacy and safety of Disitamab Vedotin combined with Penpulimab as neoadjuvant therapy in patients with HER2-low early or locally advanced breast cancer
Detailed Description: Subjects who met the criteria for admission were treated with Disitamab Vedotin20mgkgivq3w combined with Penpulimab 200mgivq3w as neoadjuvant therapy for 6 cycles before surgery and DCR and ORR were assessed before surgery All subjects who are suitable for surgery undergo surgery and evaluate their pCR rate pathological complete remission rate The postoperative treatment plan was developed according to the subjects condition and willingness

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?: None
Is an FDA AA801 Violation?: None