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Trial record 3 of 60 for:    PD-1 and breast cancer | Recruiting, Not yet recruiting, Available Studies

A Trial of SHR-1210 (an Anti-PD-1 Antibody) in Combination With Apatinib in Patients With Advanced TNBC

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ClinicalTrials.gov Identifier: NCT03394287
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary:

This is a Phase II, Open-labeled, Randomised, Parallel, Non-comparative, Two-arms, Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib (VEGFR2 inhibitor) in Subjects with Advanced Triple Negative Breast Cancer. Subjects with advanced Triple Negative Breast Cancer will be recruited. Patients will be randomised to two treatment arms of this study. One arm is SHR-1210 combination with apatinib daily dosing, and the other arm is SHR-1210 combination with apatinib intermittent dosing; each arm will enrolle10-29 subjects (Simons two stage design).

This study aims to evaluate the efficacy and safety of SHR-1210 combination with apatinib in the treatment of advanced TNBC.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: SHR-1210 Drug: Apatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-labeled, Randomised, Non-comparative, Two-arms Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib in Subjects With Advanced Triple Negative Breast Cancer
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: SHR-1210 +Apatinib daily dosing
SHR-1210 200mg(3mg/kg for patient whose weight is below 50kg) iv Q2W combination With Apatinib 250mg, po, daily dosing (d1-d14)
Drug: SHR-1210
SHR-1210 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every two weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.

Drug: Apatinib
Apatinib 250mg will be taked daily/intermittent dosing until unacceptable toxic effects or disease progression or other termination criteria appeared.

Experimental: SHR-1210+Apatinib intermittent dosing
SHR-1210 200mg (3mg/kg for patient whose weight is below 50kg) iv Q2W combination With Apatinib 250mg, po, intermittent dosing(Continuous administration for 7 days every 14 days, d1-d7)
Drug: SHR-1210
SHR-1210 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every two weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.

Drug: Apatinib
Apatinib 250mg will be taked daily/intermittent dosing until unacceptable toxic effects or disease progression or other termination criteria appeared.




Primary Outcome Measures :
  1. ORR [ Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months) ]
    Overall Response Rate


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: from the first drug administration to within 90 days for the last SHR-1210 dose ]
    adverse events/serious adverse events

  2. DCR [ Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months) ]
    Disease Control Rate

  3. DoR [ Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months) ]
    Duration of response

  4. PFS [ Time Frame: from the first drug administration up to the first occurrence of progression or death (up to about 5 years) ]
    Progression-Free-Survival

  5. One year-OS [ Time Frame: 12 months after the first drug administration ]
    One year-Overall survival

  6. CBR [ Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months) ]
    Clinical benefit rate

  7. TTR [ Time Frame: from the first drug administration up to one year ]
    Time to response

  8. Frequencies Of Biomarkers [ Time Frame: pre-dose, and up to two years ]
    Biomarkers (PD-L1, PD-1, VEGF-A, eg) in tumor tissue and peripheral blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patients signed the written informed consent
  • Women aged 18-70.
  • The pathologic diagnosis of recurrent metastatic triple negative breast cancer [ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative(IHC-/+ or IHC++ and FISH/CISH-)].
  • At least one measuring lesion that conforms to RECIST v1.1 standard.
  • The number of chemotherapy lines in the metastatic phase was <3 line.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  • Have a life expectancy of at least 12 weeks.
  • Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.
  • The patients can swallow pills.
  • The results of patients' blood tests are as follows: • Hb≥90g/L; • Plt≥90E+9/L; • Neutrophils≥1.5E+9/L; • ALT and AST ≤ triple of normal upper limit; • TBIL ≤ 1.5 times of normal upper limit; • Creatinine ≤ 1.5 times of normal upper limit.

Exclusion Criteria:

  • The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
  • Subjects with severe allergic reactions to other monoclonal antibodies.
  • The subjects had a central nervous system metastases with clinical symptoms.
  • History of hypertension and antihypertensive medications are not well controlled.
  • A heart condition or disease that is not well controlled.
  • Subjects had active infections or recent treatment with a systemic immunostimulatory agent (received within the previous 4 weeks).
  • Other clinical trials of drugs were used in the first four weeks of the first medication.
  • Subjects with treatment history of anti-angiogenesis drugs or check-point inhibitors.

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): NCT03394287


Contacts
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Contact: Erwei Song 86-13926477694 songew@mail.sysu.edu.cn
Contact: Jieqiong Liu 86-13922272706 liujieqiong01@163.com

Locations
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China, Guangdong
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Erwei Song, M.D.,Ph.D.       songew@mail.sysu.edu.cn   
Contact: Qiang Liu       victorlq@hotmail.com.com   
Principal Investigator: Erwei Song, M.D.,Ph.D.         
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Erwei Song Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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Responsible Party: Erwei Song, M.D., Ph.D., President of Sun Yat-sen Memorial Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03394287     History of Changes
Other Study ID Numbers: SHR-1210-APTN-IIT-TNBC
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antibodies
Apatinib
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action