Ignite Creation Date:
2024-05-06 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05215106
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2021-12-22
Brief Title:
Short-term Pre-OPerative Durvalumab MEDI 4736 in Early Small Triple Negative Breast Cancer Patients POP-Durva
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
Gustave Roussy Cancer Campus Grand Paris
Study Overview
Official Title:
Short-term Pre-OPerative Durvalumab MEDI 4736 in Early Small Triple Negative Breast Cancer Patients POP-Durva
Status:
RECRUITING
Status Verified Date:
2024-07
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:
POP-DURVA
Brief Summary:
This study aims to evaluate the efficacy and safety of preoperative Durvalumab in patients with early small cT1N0 triple negative breast cancer tumors This study will recruit patients with early HR-negative breast cancer all invasive types ER 10 PR 10 HER2 negative and TILs 5 eligible for a short-term treatment with Durvalumab A total of 200 patients are planned to be enrolled in the study and which will receive 2 administrations of durvalumab 10mgkg
After study treatment patients
In whom surgery is the first standard treatment strategy ie after study treatment no biopsy is required at the end-of-treatment visit
In whom neo adjuvant therapy is the first standard treatment strategy ie after study treatment a breast ultrasound guided biopsy is mandatory at the EoT visit If the biopsy-proven residual disease is demonstrated patients will have the option to receive standard neoadjuvant therapy at the discretion of the treating investigator Those with a complete response may proceed directly to surgery
After study treatment patients
In whom surgery is the first standard treatment strategy ie after study treatment no biopsy is required at the end-of-treatment visit
In whom neo adjuvant therapy is the first standard treatment strategy ie after study treatment a breast ultrasound guided biopsy is mandatory at the EoT visit If the biopsy-proven residual disease is demonstrated patients will have the option to receive standard neoadjuvant therapy at the discretion of the treating investigator Those with a complete response may proceed directly to surgery
Detailed Description:
None
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 |
|---|---|---|---|
| 20203210 | OTHER | CSET number | None |