A phase II single-arm, multicenter, open-label neoadjuvant study of pembrolizumab in combination with nab-paclitaxel followed by pembrolizumab in combination with epirubicin and cyclophosphamide in patients with triple-negative breast cancer: Neoimmunoboost.

Authors

null

Peter A. Fasching

Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany

Peter A. Fasching , Andreas Hartkopf , Hans-Christian Kolberg , Lothar Haeberle , Sarah Wetzig , Christine Mau , Tobias Engler , Matthias Rübner , Hanna Hübner , Anna-Katharin Theuser , Nadine Hummel , Sabrina Uhrig , Matthias W. Beckmann , Alexander Hein , Michael Untch

Organizations

Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg, Erlangen, Germany, Department of Women’s Health, University Hospital Tübingen, Tübingen, Germany, Department of Gynecology and Obstetrics, Marienhospital Bottrop, Bottrop, Germany, Department of Gynecology and Obstetrics, Erlangen University Hospital, Comprehensive Cancer Center Erlangen-EMN, Friedrich Alexander University of Erlangen-Nuremberg; Biostatistics Unit, Erlangen University Hospital, Department of Gynecology and Obstetric, Erlangen, Germany, Department of Gynecology and Obstetrics, Helios Klinikum Berlin-Buch, Berlin, Germany, Institut fuer Frauengesundheit (IFG) GmbH, Erlangen, Germany

Research Funding

Pharmaceutical/Biotech Company
MSD, Celgene

Background: The NeoImmunoboost study (NCT03289819) was designed to evaluate the pathological complete response (pCR) rate and safety of a neoadjuvant combination of the PD-1 antibody pembrolizumab and nab-paclitaxel followed by pembrolizumab with epirubicin and cyclophosphamide in patients with early triple negative breast cancer (TNBC). Methods: This is a prospective, single-arm, multi-center, open-label phase II clinical trial. Female patients with early TNBC were eligible for trial participation. Patients received 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w. After 25 patients the protocol was amended, with an initiation boost of 1 cycle of pembrolizumab i.v. 200 mg q3w monotherapy prior to the chemotherapy. Primary trial endpoint was pCR. Secondary endpoints included safety and clinical response rate. Results: Between March 2018 and October 2019, 53 patients were included into the trial. Until now, 47 patients have completed trial treatment and 6 patients are still receiving therapy. 28 patients have received the initiation boost with pembrolizumab, 25 patients did not receive the initiation boost. Up to now, 4 patients terminated the therapy prematurely. Conclusions: pCR data of all patients will be available at the meeting and results of the pCR rates and selected secondary endpoints will be presented at the meeting. Clinical trial information: NCT03289819

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Publication Only

Session Title

Publication Only: Breast Cancer - Local/Regional/Adjuvant

Track

Breast Cancer

Sub Track

Neoadjuvant Therapy

Clinical Trial Registration Number

NCT03289819

Citation

J Clin Oncol 38: 2020 (suppl; abstr e12647)

DOI

10.1200/JCO.2020.38.15_suppl.e12647

Abstract #

e12647

Abstract Disclosures