Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 87 for:    PD-1 and breast cancer
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03151447
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Xiaomao Guo, Fudan University

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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Radiation: stereotactic body radiation therapy Phase 1

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Stereotactic Body Radiation Therapy With Concurrent Anti-PD1antibody (JS001) injected intravenously 120mg or 240mg or 360mg until disease progresses or unacceptable tolerability occurs
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Stereotactic Body Radiation Therapy Combined With Anti-PD-1 Antibody in Patients With Metastatic Triple Negative Breast Cancer
Actual Study Start Date : March 6, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: SBRT in combined with anti-PD-1 antibody
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

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.





Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  • 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:

    1. neutrophils ≥1.5×109/L
    2. Platelets ≥100×109/L
    3. Hemoglobin ≥90g/L (no blood transfusion within past 14 days)
    4. Serum Cr ≤1×ULN, endogenous creatinine clearance rate >50ml/min (Cockcroft-Gault formula)
    5. AST ≤2.5×ULN, ALT ≤2.5×ULN; both ALT and AST ≤5×ULN if there are liver metastasis
    6. Total bilirubin ≤ 1.5 × ULN (except for patients with Gilbert syndrome, the total bilirubin of those patients must be <51.3μmol/L)
    7. TSH, FT3, FT4 are within ± 10% of the normal range.

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;
  • 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;
  • Prior therapy with monoclonal antibodies within past 3 months (except for locally administration);
  • History of other malignant tumors. (Except for non-melanoma skin cancer and the following carcinomas in situ: bladder, stomach, colon, endometrium, cervical / dysplasia, melanoma or breast cancer). Patients who have obtained complete response for at least 2 years prior to enrollment and don't need receive other treatment should be included;
  • Underlying medical conditions, according to the investigator, that would increase the risks of study drug administration or obscure the interpretation of adverse events;
  • Chronic hepatitis B (HBs Ag positive) or chronic hepatitis C (HCV antibody positive);
  • Patients with known sensitivity or allergy to any components of humanized anti-PD-1 antibody.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151447


Contacts
Layout table for location contacts
Contact: Xiaomao Guo +86 guoxm1800@126.com
Contact: LI Zhang +8613818119034 zhangliaaa111@163.com

Locations
Layout table for location information
China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China, 200032
Contact: Xiaomao Guo, Ph.D       guoxm1800@126.com   
Sponsors and Collaborators
Fudan University

Layout table for additonal information
Responsible Party: Xiaomao Guo, The President of Fudan University Shanghai Cancer Center, Fudan University
ClinicalTrials.gov Identifier: NCT03151447     History of Changes
Other Study ID Numbers: FDRT-BC005
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiaomao Guo, Fudan University:
Breast Cancer
Anti-PD1 Antibody
Stereotactic Body Radiation Therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs