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ACTIVE NOT RECRUITING
NCT03125928
PHASE2

Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer

Sponsor: Fox Chase Cancer Center

View on ClinicalTrials.gov

Summary

This is a single arm, Phase IIA clinical trial assessing the safety and efficacy of atezolizumab in combination with paclitaxel, trastuzumab, and pertuzumab in 50 patients with locally advanced, unresectable, or metastatic HER2-overexpressing breast cancer. Due to concerns that corticosteroids may have a negative effect on tumor immunity expected with addition of atezolizumab to the standard of care regimen, patients will receive premedication with dexamethasone only for weeks 1 and 2 of the weekly paclitaxel, and then corticosteroid premedication will be discontinued subsequently. Patients must have pathologically confirmed HER2-overexpressing breast cancer that is locally recurrent, unresectable, or metastatic, with measurable disease as defined by RECIST v1.1. Tumor measurements and bone scans will be performed every 9 weeks while patients are on study.

Official title: Single Arm, Phase IIA Clinical Trial Assessing The Safety And Efficacy of Atezolizumab in Combination With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

16

Start Date

2017-06-13

Completion Date

2025-12

Last Updated

2025-01-10

Healthy Volunteers

No

Interventions

DRUG

Atezolizumab

Monoclonal antibody

DRUG

Paclitaxel

Chemotherapy

DRUG

Trastuzumab

Monoclonal antibody

DRUG

Pertuzumab

Monoclonal antibody

Locations (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States