Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title: Phase II Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate pembrolizumab therapy in patients with triple-negative breast cancer (TNBC) who have received at least one prior line of therapy.

Clinical Trial Description

This phase II, single-arm, multicenter study will evaluate efficacy and toxicity of administration of pembrolizumab following cyclophosphamide therapy, in advanced stage triple-negative breast cancer.

Duration of Therapy

Treatment may continue until one of the following occurs:

• Disease progression

• Inter-current illness that prevents further administration of treatment

• Unacceptable adverse event(s)

• Pregnancy

• Patient decides to withdraw from study treatment,

• General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator

• Completed 24 months of uninterrupted treatment with pembrolizumab or 35 administrations of study medication, whichever is later

Duration of Follow Up

• Subjects will be followed for up to 3 years after removal from study treatment or until death, whichever occurs first.

• Patients removed from study for unacceptable adverse events (AEs) will be followed until resolution or stabilization of the event(s). ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

• NCT number: NCT02768701
• Study type: Interventional
• Source: UNC Lineberger Comprehensive Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: October 18, 2016
• Completion date: May 1, 2023