Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Metastatic Triple Negative Breast Cancer

NCT03151447 | Unknown Phase 1 DMC

• 1 other identifier: FDRT-BC005
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Breast Cancer

Keywords

Breast Cancer; Anti-PD1 Antibody; Stereotactic Body Radiation Therapy

Outcome Measures

Primary Outcomes (1)

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

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

  3 years

Study Arms (1)

SBRT in combined with anti-PD-1 antibody

EXPERIMENTAL

Patients will receive stereotactic body radiation therapy to metastatic lesions of liver, lung, bone, brain or lymph nodes and concurrent anti-PD-1 antibody treatment.

Radiation: stereotactic body radiation therapy

Interventions

stereotactic body radiation therapy RADIATION

In patients with metastatic triple negative breast cancer, stereotactic body radiation therapy will be combined with anti-PD-1 antibody. Stereotactic body radiation therapy: SBRT is delivered to 1\~5 measurable metastatic lesions of liver, lung, bone, brain or lymph nodes in limited fractions . Anti-PD-1 treatment: anti-PD-1 antibody (JS001) is injected intravenously 120mg or 240mg or 360mg every two weeks.

SBRT in combined with anti-PD-1 antibody

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ECOG performance status score of 0 or 1
• There must be at least 4 weeks since the last radiotherapy, chemotherapy, hormone therapy and molecular targeted therapy. Patients must have recovered from any toxicity related to prior therapy and the toxicity should be less than or equal to grade 1 (according to CTCAE 4.03) or returned to baseline.
• A systemic medication (such as corticosteroids) with an immunosuppressive dose (prednisone\> 10 mg/d or equivalent dose) must have been discontinued for at least 2 weeks before the initiation of the study drug.
• Surgeries requiring general anesthesia must have been completed for at least 4 weeks before the initiation of the study drug. Surgeries requiring local anesthesia or epidural anesthesia must have been completed for at least 72 hours and the patients have recovered from these surgeries. Skin biopsy that needs local anesthesia must have been completed for at least 1 hour.
• The Laboratory test results must meet the following criteria:

You may not qualify if:

• 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;
• Pregnancy and breastfeeding
• Patients that can't receive intravenous puncture and/or venous access;
• History of other medical, psychological or social reasons as determined by the investigator;
• History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity;
• Prior traditional Chinese medicine therapy with antitumor activity within past 2 weeks;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Xiaomao Guo

CONTACT

+86; guoxm1800@126.com

LI Zhang

CONTACT

+8613818119034; zhangliaaa111@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The President of Fudan University Shanghai Cancer Center

Model Details: Stereotactic Body Radiation Therapy With Concurrent Anti-PD1antibody (JS001) injected intravenously 120mg or 240mg or 360mg until disease progresses or unacceptable tolerability occurs

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 12, 2017
• Study Start: March 6, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 12, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)