Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06643585
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in EBC Patients with Molecular Relapse
Sponsor:
None
Organization:
None
Study Overview
Official Title:
SURVIVE HERoes - a Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in EBC Patients with Molecular Relapse
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
SURVIVE HERoes
Brief Summary:
Prospective multi-center randomized open label comparative Phase III study in patients with intermediate to high-risk as defined in the SURVIVE trial HER2-positive or HER2-low early breast cancer who participate in the SURVIVE trial and experience a molecular relapse as assessed based on a positive circulating tumor DNA ctDNA result with 21 allocation to
Arm A Trastuzumab-Deruxtecan iv 54 mgkg q3w endocrine therapy if hormonal-receptor-positive for 16 cycles or until relapse if earlier
Arm B Continuous treatment of physicians choice may include endocrine treatment CDK46-Inhibition T-DM1 Olaparib Trastuzumab Pertuzumab Capecitabine or Neratinib
Arm A Trastuzumab-Deruxtecan iv 54 mgkg q3w endocrine therapy if hormonal-receptor-positive for 16 cycles or until relapse if earlier
Arm B Continuous treatment of physicians choice may include endocrine treatment CDK46-Inhibition T-DM1 Olaparib Trastuzumab Pertuzumab Capecitabine or Neratinib
Detailed Description:
None
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