Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06105008
Status:
WITHDRAWN
Last Update Posted:
2024-02-21
First Post:
2023-10-23
Brief Title:
Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive HER2-low Locally Advanced or Metastatic Breast Cancer
Sponsor:
RemeGen Co Ltd
Organization:
RemeGen Co Ltd
Study Overview
Official Title:
An Randomized Open-label Multicenter Phase 2 Study Comparing the Efficacy and Safety of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin Monotherapy in Subjects With Endocrine-resistant Hormone Receptor-positive HER2-Low Unresectable Locally Advanced or Metastatic Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the companys strategic adjustment non-security related
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the efficacy safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor HR positive human epidermal growth factor receptor HER2-low advanced breast cancer
Detailed Description:
Eligible patients will be those patients who have had disease progression on at least 1 previous line of endocrine therapies given for the treatment of metastatic disease or relapsed within 12 months of the end of adjuvant endocrine therapy or during adjuvant endocrine therapy patients treated with CDK46 inhibitors require 50 All patients must have historically confirmed HR positive HER2-low defined as IHC2ISH- and IHC 1 expression as determined by central laboratory testing results advanced breast cancer IHC 1 account for no more than 60 The study aims to evaluate the efficacy safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC This study aims to see if RC48-ADC with JS001 allows patients to live longer without the cancer getting worse compared to patients receiving RC48-ADC This study is also looking to see how the treatment and the cancer affects patients quality of life
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