NCT02685059

Addition of PD-L1 Antibody MEDI4736 to a Taxane-anthracycline Chemotherapy in Triple Negative Breast Cancer

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: GBG Forschungs GmbH · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	MEDI4736 (Anti PD-L1)	MEDI4736 1.5g total i.v. every 4 weeks As monotherapy for the first two weeks (0.75g absolute) (part 1) followed by: MEDI4736 in combination with nab-paclitaxel 125 mg/m² every week for 12 weeks (part 2) followed by MEDI4736 in combination with epirubicin 90mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for 4 cycles (part 3).
DRUG	Placebo	Placebo i.v. every 4 weeks As monotherapy for the first two weeks (0.75g absolute) (part 1) followed by: Placebo in combination with nab-paclitaxel 125 mg/m² every week for 12 weeks (part 2) followed by MEDI4736/Placebo in combination with epirubicin 90mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for 4 cycles (part 3).
DRUG	nab-Paclitaxel	nab-Paclitaxel 125 mg/m² weekly for 12 weeks
DRUG	Epirubicin	Epirubicin 90 mg/m² 2-weekly for 8 weeks
DRUG	Cyclophosphamide	Cyclophosphamide 600 mg/m² 2-weekly for 8 weeks

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2016-02-18
• Last updated: 2021-02-15

Locations

1 site across 1 country: Germany