Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-06-24 @ 11:09 PM
Study NCT ID:
NCT02685059
Status:
COMPLETED
Last Update Posted:
2021-02-15
First Post:
2016-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addition of PD-L1 Antibody MEDI4736 to a Taxane-anthracycline Chemotherapy in Triple Negative Breast Cancer
Sponsor:
GBG Forschungs GmbH
Organization:
Study Overview
Official Title:
A Randomized Phase II Study to Investigate the Addition of PD-L1 Antibody MEDI4736 to a Taxane-anthracycline Containing Chemotherapy in Triple Negative Breast Cancer (GeparNuevo)
Status:
COMPLETED
Status Verified Date:
2021-02
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:
GeparNuevo
Brief Summary:
To date no targeted agents are available to treat TNBC. Therefore chemotherapy is the only treatment option. TNBC often has a high amount of tumour infiltrating lymphocytes. Stimulating the immune cells of TNBC might therefore be an option for these patients to increase the pathological complete response. pCR is highly correlated with outcome in TNBC.
Therefore the addition of a checkpoint inhibitor in addition to chemotherapy might be an additional option for these patients.
Therefore the addition of a checkpoint inhibitor in addition to chemotherapy might be an additional option for these patients.
Detailed Description:
To date no targeted agents are available to treat TNBC. Therefore chemotherapy is the only treatment option. TNBC often has a high amount of tumour infiltrating lymphocytes. Stimulating the immune cells of TNBC might therefore be an option for these patients to increase the pathological complete response. pCR is highly correlated with outcome in TNBC.
Therefore the addition of a checkpoint inhibitor in addition to chemotherapy might be an additional option for these patients.
The primary objective therefore is to compare the pathological complete response (pCR= ypT0 ypN0) rates of neoadjuvant treatment of sequential, nab-Paclitaxel followed by EC +/- the PD-L1 antibody MEDI4736 in patients with early triple negative breast cancer.
Therefore the addition of a checkpoint inhibitor in addition to chemotherapy might be an additional option for these patients.
The primary objective therefore is to compare the pathological complete response (pCR= ypT0 ypN0) rates of neoadjuvant treatment of sequential, nab-Paclitaxel followed by EC +/- the PD-L1 antibody MEDI4736 in patients with early triple negative breast cancer.
Study Oversight
Has Oversight DMC:
True
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?: