Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04897009
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2021-05-18
Brief Title:
Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Operable Breast Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Evaluating the Impact of Neoadjuvant Chemotherapy on the Peripheral Blood Immune Phenotype in Patients With Operable Breast Cancer ENHANCE
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
ENHANCE
Brief Summary:
This early phase I trial evaluates the impact of chemotherapy before surgery neoadjuvant on the peripheral blood immune phenotype in patients with operable breast cancer Collecting blood and information from patients with breast cancer may help to understand how the immune system influences response to treatment and how the immune system reacts to breast cancer treatment
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate whether pre-neoadjuvant chemotherapy NAC peripheral blood immune phenotypes defined by mass cytometry are associated with pathologic complete response pCR after neoadjuvant chemotherapy in patients with operable breast cancer
II To evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls
SECONDARY OBJECTIVES
I To characterize changes in the baseline peripheral blood immune phenotype that arise as a consequence of neoadjuvant chemotherapy
II To create a biorepository of peripheral blood samples for future research in breast cancer including circulating tumor deoxyribonucleic acid ctDNA epigenetic and functional studies
EXPLORATORY OBJECTIVE
I To evaluate differences in peripheral blood immune phenotype of patients with oligometastatic breast cancer compared to patients with stage I-III breast cancer
OUTLINE
Patients undergo blood sample collection at baseline prior to first NAC treatment after taxane and prior to first dose of anthracyclinecyclophosphamide AC for patients receiving a taxane end of NAC 1-4 weeks and 6 months post-surgery Patients also undergo tissue collection at 1-4 weeks and 6 months post-surgery
After completion of study treatment patients are followed up every 6 months for up to 5 years
I To evaluate whether pre-neoadjuvant chemotherapy NAC peripheral blood immune phenotypes defined by mass cytometry are associated with pathologic complete response pCR after neoadjuvant chemotherapy in patients with operable breast cancer
II To evaluate whether the baseline peripheral blood immune phenotype differs between patients with breast cancer and age-matched healthy controls
SECONDARY OBJECTIVES
I To characterize changes in the baseline peripheral blood immune phenotype that arise as a consequence of neoadjuvant chemotherapy
II To create a biorepository of peripheral blood samples for future research in breast cancer including circulating tumor deoxyribonucleic acid ctDNA epigenetic and functional studies
EXPLORATORY OBJECTIVE
I To evaluate differences in peripheral blood immune phenotype of patients with oligometastatic breast cancer compared to patients with stage I-III breast cancer
OUTLINE
Patients undergo blood sample collection at baseline prior to first NAC treatment after taxane and prior to first dose of anthracyclinecyclophosphamide AC for patients receiving a taxane end of NAC 1-4 weeks and 6 months post-surgery Patients also undergo tissue collection at 1-4 weeks and 6 months post-surgery
After completion of study treatment patients are followed up every 6 months for up to 5 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA015083 | NIH | Mayo Clinic Institutional Review Board | httpsreporternihgovquickSearchP30CA015083 |
| NCI-2021-04162 | REGISTRY | None | None |
| P50CA116201 | NIH | None | None |
| 20-010563 | OTHER | None | None |