NCT05174832

Induction of Cisplatin/Nab-paclitaxel/Pembrolizumab Followed by Olaparib/Pembrolizumab Maintenance in mTNBC Patients

Induction of Cisplatin/Nab-paclitaxel/Pembrolizumab Followed by Olaparib/Pembrolizumab Maintenance in Triple-negative Metastatic Breast Cancer Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate if olaparib plus pembrolizumab will maintain the clinical benefit achieved after induction therapy with Albumin-bound paclitaxel combined with cisplatin(AP) regimen and pembrolizumab in previously untreated locally advanced, recurrent or metastatic TNBC population with PD-L1 CPS≥1.

Detailed description

TNBC is a hard-to-treat disease requiring continuous administration of drugs, necessitating further exploration of optimal maintenance strategy. However, there are currently no standard maintenance treatment regimens in the treatment of mTNBC. KEYNOTE-355 has already proved pembrolizumab has durable antitumor activity and manageable safety in patients with metastatic TNBC. Olaparib is now established as maintenance therapy for platinum-sensitive populations regardless of BRCA status in the setting of other tumor types. Furthermore, preclinical and clinical data indicates that olaparib and pembrolizumab combination have an improved therapeutic effect, showing promising synergistic benefits. Therefore, adding olaparib to pembrolizumab after induction treatment with a platinum-based regimen plus pembrolizumab will high likely change and expand the treatment paradigm in this disease, particularly for those patients with platinum-sensitive TNBC tumors. Olaparib plus pembrolizumab has the potential for further treatment benefit as a chemo-sparing regimen.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	75 mg/m2 IV days 1 of each 21-day cycle
DRUG	Nab-paclitaxel	125 mg/m2 IV days 1 and 8 of each 21-day cycle
DRUG	Pembrolizumab	200 mg IV every 21 days
DRUG	Olaparib	300 mg PO BID

Timeline

• Start date: 2022-09-07
• Primary completion: 2023-12-01
• Completion: 2025-03-01
• First posted: 2022-01-03
• Last updated: 2023-09-28

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study