Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05693766
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-01-11
Brief Title:
Gene Signatures to Guide HRMBC Therapy in a Diverse Cohort
Sponsor:
Sonya Reid
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Integrating Gene Signatures to Guide HRMBC Therapy in a Diverse Cohort INSIGHT
Status:
RECRUITING
Status Verified Date:
2024-04
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:
INSIGHT
Brief Summary:
This is an open-label multicenter two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy ie capecitabine on survival in patients with non-Luminal A hormone receptor-positive HR metastatic breast cancer MBC
Detailed Description:
Primary Objective
- Determine the impact of early chemotherapy ie capecitabine versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive HR metastatic breast cancer
Secondary Objectives
Compare the safety and tolerability of capecitabine versus endocrine therapy in patients with non-Luminal A hormone receptor-positive HR metastatic breast cancer
Determine the impact of early chemotherapy ie capecitabine versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive HR metastatic breast cancer
Correlatives
Determine if the tumor mutations detected in cfDNA are early surrogates of response
Determine if the cfDNA results at disease progression show new genomic alterations potentially associated with resistance to therapy
- Determine the impact of early chemotherapy ie capecitabine versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive HR metastatic breast cancer
Secondary Objectives
Compare the safety and tolerability of capecitabine versus endocrine therapy in patients with non-Luminal A hormone receptor-positive HR metastatic breast cancer
Determine the impact of early chemotherapy ie capecitabine versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive HR metastatic breast cancer
Correlatives
Determine if the tumor mutations detected in cfDNA are early surrogates of response
Determine if the cfDNA results at disease progression show new genomic alterations potentially associated with resistance to therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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