Phase Ib/II Study to Assess Efficacy, Safety & Immunological Biomarker of Anti PD-1 Antibody With Radiation Therapy in Patients With HER2-negative Metastatic Breast Cancer

Kyoto Breast Cancer Research Network1 site in 1 country32 target enrollmentJune 22, 2017

ConditionsBreast Cancer

InterventionsCohort A

DrugsCohort A

Overview

Phase: Phase 1
Intervention: Cohort A
Conditions: Breast Cancer
Sponsor: Kyoto Breast Cancer Research Network
Enrollment: 32
Locations: 1
Primary Endpoint: Phase Ib : dose-limiting toxicity rate
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to evaluate the safety and efficacy of anti PD-1 antibody with radiation therapy in patients with HER2-negative metastatic breast cancer.

Registry

clinicaltrials.gov

Start Date

June 22, 2017

End Date

April 1, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Kyoto Breast Cancer Research Network

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Documentation of ER-positive and/or PR-positive tumor (\>=1% positive stained cells) .
•Patients must satisfy the following criteria for prior therapy:
•Progressed during treatment or within 12 months of completion of adjuvant hormone therapy.
•or Progressed while prior hormone therapy for advanced/metastatic breast cancer. Two previous line of hormone therapy for advanced/metastatic disease is allowed.
•Patients who have hormone therapy that can be expected for advanced /metastatic disease.
•Patients who have come to be non-responsive more than two line of chemotherapy
•Prior chemotherapy with anthracycline and taxane agent
•Cohort A and B
•Female patients who are histologically or cytologically confirmed to have breast cancer
•Patients who have distant metastatic lesion as follow

Exclusion Criteria

•Exclusion Criteria:
•Patients who have neuropathy (more than Grade 2)
•Patients with any active autoimmune disease or a history of known autoimmune disease.
•Patients who has a history of pneumonitis or interstitial lung disease.
•Active, untreated central nervous system metastasis.
•Patients with pericardial effusion, pleural effusion or ascites requiring treatment
•Patients with uncontrolled diabetes mellitus
•Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 28 days of the enrollment.
•Patients who has received radiotherapy within 28 days of study registration, or radiotherapy for thorax within 56 days of the enrollment.
•Pregnant or breast-feeding women.