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

Sponsor
Fudan University
Study ID
NCT05174832
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 7, 2022
Status verified
Nov 2022
Primary completion
Dec 1, 2023
Completion
Mar 1, 2025

Study Design

Enrollment
136 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cisplatin+ Nab-paclitaxel + Pembrolizumab followed by Pembrolizumab monotherapy
    4\~6 cycles combination therapy of Cisplatin, Nab-paclitaxel and Pembrolizumab as induction therapy; Pembrolizumab monotherapy as maintenance therapy
  • Experimental: Cisplatin+Nab-paclitaxel+Pembrolizumab followed by Pembrolizumab+Olaparib
    4\~6 cycles combination therapy of Cisplatin, Nab-paclitaxel and Pembrolizumab as induction therapy; Pembrolizumab plus Olaparib as maintenance therapy

Primary Outcome Measure

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by local investigators [ Time Frame: Up to 36 months ]

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