Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318897
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-03-13
Brief Title:
Open-label Single Center Single-arm Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Open-label Single Center Single-arm Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
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 look at the effectiveness of the combination of pembrolizumab carboplatin and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer
Detailed Description:
Primary Objective To estimate the rate of pCR in patients with cT1b and T1cN0M0 TNBC after neoadjuvant therapy with 4 cycles of Pembrolizumab Carboplatin Paclitaxel
Secondary Objective To assess the safety and toxicity profile of pembrolizumab plus chemotherapy in participants receiving an anthracycline-de-escalated regimen of carboplatin paclitaxel and pembrolizumab by recording the incidence of treatment emergent adverse events
Exploratory Objectives
1 To estimate the invasive disease-free survival iDFS and overall survival OS in participants with cT1b-T1cN0 TNBC that receive neoadjuvant pembrolizumab plus chemotherapy in the setting of an anthracycline de-escalation study
2 To explore if there is a molecular signature associated with response or lack of response to therapy
3 To evaluate patient reported outcomes of participants receiving this de-escalated regimen
Secondary Objective To assess the safety and toxicity profile of pembrolizumab plus chemotherapy in participants receiving an anthracycline-de-escalated regimen of carboplatin paclitaxel and pembrolizumab by recording the incidence of treatment emergent adverse events
Exploratory Objectives
1 To estimate the invasive disease-free survival iDFS and overall survival OS in participants with cT1b-T1cN0 TNBC that receive neoadjuvant pembrolizumab plus chemotherapy in the setting of an anthracycline de-escalation study
2 To explore if there is a molecular signature associated with response or lack of response to therapy
3 To evaluate patient reported outcomes of participants receiving this de-escalated regimen
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-02384 | OTHER | NCI-CTRP Clinical Registry | None |