Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606730
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
OPTimizing Adjuvant Prescription of PEMBROlizumab in Patients With Early-stage Triple-negative Breast Cancer Achieving Pathologic Complete Response After Standard Neoadjuvant Chemotherapy and Pembrolizumab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPT-PEMBRO
Brief Summary:
OPT-PEMBRO trial is a pragmatic multicentre international prospective non-inferiority two-arms randomised 11 open-label Phase III clinical study
The main goal of this research is to determine if patients with triple-negative breast cancer who experience a complete response after neoadjuvant treatment have the same chance of avoiding cancer recurrence whether they stop pembrolizumab or continue taking it for an additional 6 months
This research will also take into account patients tolerance to treatment and quality of life
The main goal of this research is to determine if patients with triple-negative breast cancer who experience a complete response after neoadjuvant treatment have the same chance of avoiding cancer recurrence whether they stop pembrolizumab or continue taking it for an additional 6 months
This research will also take into account patients tolerance to treatment and quality of life
Detailed Description:
Triple-negative breast cancer is a particular type of breast cancer in which the cancer cells do not possess receptors for the proteins estrogen progesterone or HER2 The usual treatment for early-stage triple-negative breast cancer consists of chemotherapy and immunotherapy a treatment in this case pembrolizumab designed to stimulate the bodys immune defenses against cancer cells for 6 months before surgery followed by a further 6 months of immunotherapy after surgery Although this sequence is the reference treatment the addition of an immunotherapy extension after surgery may not bring any additional benefit in patients who have had an excellent response to neoadjuvant treatment before surgery demonstrated by tumor disappearance at the time of surgery and who therefore have a good prognosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None