NCT02768701

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Subjects will be treated every 3 weeks with 200 mg of pembrolizumab via a 30 minute infusion.
DRUG	Cyclophosphamide	A single 300 mg/m2 dose of cyclophosphamide IV over 30-60 minutes will be administered on Day 1 of this study.

Timeline

• Start date: 2016-10-18
• Primary completion: 2022-05-01
• Completion: 2023-05-01
• First posted: 2016-05-11
• Last updated: 2023-05-22
• Results posted: 2022-08-03

Locations

5 sites across 1 country: United States