A Phase I Trial of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients With Metastatic Triple Negative Breast Cancer

Fudan University1 site in 1 country18 target enrollmentMarch 6, 2017

ConditionsMetastatic Breast Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Metastatic Breast Cancer
Sponsor: Fudan University
Enrollment: 18
Locations: 1
Primary Endpoint: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the safety and tolerance of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients in Metastatic Triple Negative Breast Cancer

Detailed Description

The objective of this study is to evaluate the safety and tolerance of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody（JS001） in Patients With Metastatic Triple Negative Breast Cancer

Registry

clinicaltrials.gov

Start Date

March 6, 2017

End Date

March 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Xiaomao Guo

The President of Fudan University Shanghai Cancer Center

Fudan University

Eligibility Criteria

Inclusion Criteria

•Patients must be able to understand and willing to sign a written informed consent document.
•Patients with advanced triple-negative breast cancer (histologically or cytologically confirmed invasive breast carcinoma with estrogen receptor negative, progesterone receptor negative, human epidermal growth factor receptor 2 negative).
•Patients must have progressed on or been intolerant of at least prior first-line systemic treatment with anthracycline and/or taxane drugs for metastatic disease. There are no any routine regimens.
•At least 5-8 pieces of pathological tissue can be provided (for the detection of PD-L1 expression and the infiltrating lymphocytes).
•Patients must have at least one metastatic lesion with diameter\> 1 cm that is amenable to SBRT, as determined by radiation oncologist.
•Patients must be able to withstand the radiotherapy process, such as maintaining the position, etc.
•Patients must have at least 2 measurable lesions (based on RECIST V1.1);
•Female aged 18 to 75 years old are eligible.
•Weight ≥40kg
•Life expectancy ≥6 months

Exclusion Criteria

•Evidence with active central nervous system (CNS) metastases. Patients can be included if the CNS metastasis can be treated and the neurological symptoms can be restored to a level of ≤1 degree of CTCAE (except for residual signs or symptoms associated with CNS treatment) for at least 2 weeks before the enrollment. In addition, patients must have not be treated with a corticosteroid, or just be treated with a stable dose of ≤ 10 mg prednisone/day (or equivalent dose) or with a dose reduced to 10 mg prednisone/day;
•Patients with cancerous meningitis
•The same part of body has been irradiated previously;
•Patients with active, known or suspected autoimmune diseases. Patients with the following conditions can be selected: vitiligo, type I diabetes, residual thyroid dysfunction caused by autoimmune thyroiditis that just need hormone replacement therapy, or diseases that will not relapse without external stimulating factors;
•Any prior immune checkpoint inhibition treatment with anti-PD-1/PD-L1 /PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on the T cell co-stimulus or checkpoint pathway)
•Evidence of active pulmonary tuberculosis (TB). Patients diagnosed with active tuberculosis infection within 1 year should be excluded even if they have been treated. Patients diagnosed with active tuberculosis infection for more than 1 year must be excluded unless previous anti-tuberculosis treatment is effective;
•Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);
•Complications that require immunosuppressive drugs or systemic or topical corticosteroids with immunosuppressive doses;
•Prior treatment of other study drug within past 28 days, or though the internal is more than 28 days, precious study drug is still in the 5 half-life periods;
•Inoculation of any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within past 4 weeks;

Outcomes

Primary Outcomes

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Time Frame: 3 years

The incidence and severity of adverse events, clinically significant abnormal laboratory results, ECG and vital signs were assessed according to CTCAE4.03