Ignite Creation Date:
2024-05-06 @ 9:25 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02971748
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-19
First Post:
2016-11-21
Brief Title:
Pembrolizumab in Treating Patients With Hormone Receptor Positive Localized Inflammatory Breast Cancer Who Are Receiving Hormone Therapy and Did Not Achieve a Pathological Complete Response to Chemotherapy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Study of Anti-PD-1 Pembrolizumab in Combination With Hormonal Therapy During or After Radiation in Patients With Hormone Receptor HR-Positive Localized Inflammatory Breast Cancer IBC Who Did Not Achieve a Pathological Complete Response pCR to Neoadjuvant Chemotherapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
This phase II trial studies how well pembrolizumab works in treating patients with hormone receptor positive inflammatory breast cancer that has not spread to other parts of the body who are receiving hormone therapy and did not achieve a pathological complete response to chemotherapy Immunotherapy with monoclonal antibodies such as pembrolizumab may help the bodys immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread
Detailed Description:
PRIMARY OBJECTIVES
I To determine the disease free survival DFS at 2 years of patients with maintenance therapy using pembrolizumab in combination with standard adjuvant hormonal therapy
II To determine the safety and toxicity profile of primary inflammatory breast cancer IBC patients who received combination of pembrolizumab and hormone receptor blockade
EXPLORATORY OBJECTIVES
I To investigate the association between immune related biomarkers in the peripheral blood and tumor tissue such as PD-L1 expression with safety and efficacy for IBC patients treated with pembrolizumab
OUTLINE
Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 1 and 24 months
I To determine the disease free survival DFS at 2 years of patients with maintenance therapy using pembrolizumab in combination with standard adjuvant hormonal therapy
II To determine the safety and toxicity profile of primary inflammatory breast cancer IBC patients who received combination of pembrolizumab and hormone receptor blockade
EXPLORATORY OBJECTIVES
I To investigate the association between immune related biomarkers in the peripheral blood and tumor tissue such as PD-L1 expression with safety and efficacy for IBC patients treated with pembrolizumab
OUTLINE
Patients receive pembrolizumab intravenously IV over 30 minutes on day 1 Cycles repeat every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 1 and 24 months
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-0096 | OTHER | M D Anderson Cancer Center | None |
| NCI-2018-01297 | REGISTRY | None | None |