NCT03121352

Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer

Pilot Study of Carboplatin, Nab-Paclitaxel and Pembrolizumab for Metastatic Triple-Negative Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see how effective the combination of the two chemotherapy drugs (carboplatin and nab-paclitaxel) are when added to a third drug, pembrolizumab. Pembrolizumab is an investigational (experimental) drug that works by reinvigorating the immune system, allowing it to target and destroy cancer cells. Pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA) for this type of breast cancer treatment.

Detailed description

Primary Objective - Determine overall response rate (ORR) in patients treated with CNP Secondary Objective(s) * Determine progression-free survival (PFS), and disease control rate (DCR) in patients treated with CNP. * Determine duration of response in patients treated with CNP. * Determine safety/tolerability of CNP. Correlative Endpoints \- Identify pathologic and genomic correlates of response to CNP. Study design including dose escalation / cohorts This is prospective pilot clinical trial of CNP in up to 30 patients with mTNBC

Conditions

• Metastatic Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	AUC 4.5 IV day 1 of 21-day cycle
DRUG	Nab-paclitaxel	75mg/m2 IV days 1, 8 and 15 of 21-day cycle
DRUG	Pembrolizumab	200 mg IV every 21 days

Timeline

• Start date: 2017-05-19
• Primary completion: 2022-02-20
• Completion: 2022-05-23
• First posted: 2017-04-20
• Last updated: 2023-10-06
• Results posted: 2023-10-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study