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SHR-1210 Combined With Albumin-bound Paclitaxel and Epirubicin Neoadjuvant for Triple Negative Breast Cancer

Primary Purpose

Triple-negative Breast Cancer

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SHR-1210+Albumin-bound paclitaxel + epirubicin
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple-negative Breast Cancer

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Newly treated female patients aged ≥18 years and ≤60 years; 2. ECOG score 0 ~ 1 points; 3. Pathologically confirmed, the core biopsy of breast tumor lesions identified patients with TNBC breast cancer; Note: ER and PR negatives are defined as ≤ 10% of cells expressing hormone receptors by IHC (immunohistochemistry) analysis. HER2 (human epidermal growth factor receptor 2) negative is defined as any of the following assessments: non-amplified in situ hybridization (ISH) (ratio ≤ 2.2), or IHC 0 or IHC 1+; 4. Evaluate measurable tumor lesions by ultrasound or magnetic resonance imaging (MRI) within 21 days before enrollment, size ≥2cm; 5. The main organs function normally, that is, they meet the following criteria:

    1. Blood routine examination standards must meet: ANC ≥1.5 × 109 / L; PLT ≥90 × 109 / L; Hb ≥90g / L;
    2. Biochemical examination must meet the following standards: TBIL ≤ upper limit of normal value (ULN); ALT and AST ≤ 1.5 times the upper limit of normal value (ULN); alkaline phosphatase ≤ 2.5 times the upper limit of normal value (ULN); BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥50 mL / min (CockcroftGault formula);
    3. The coagulation test standard must meet: the international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN, and the activated partial thromboplastin time (aPTT) ≤ 1.5x ULN;
    4. Color Doppler ultrasound and echocardiography: left ventricular ejection fraction (LVEF≥55%);
    5. 18-lead electrocardiogram Fridericia-corrected QT interval (QTcF) for women <470 ms; 6. No evidence of distant metastases, including bilateral mammograms, breast ultrasounds; 7. Provide core biopsies from tumor lesions before treatment begins to confirm TNBC status and biomarker analysis; 8. For women who are not menopausal or not undergoing surgical sterilization: agree to abstinence or use an effective method of contraception during treatment and at least 7 months after the last dose during study treatment; 9. Sign the informed consent.

Exclusion Criteria:

  • 1. Inflammatory breast cancer or stage IV (metastatic) breast cancer; 2. Have previously been treated with anti-PD-1, anti-PD-L1, anti-PD-L2 drugs or drugs that target another co-inhibitory T cell receptor (eg CTLA-4, OX-40, CD137); 3. Have previously received antitumor treatment or radiation therapy for any malignant tumor, excluding cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; 4. Also receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphate therapy or immunotherapy; 5. Have undergone major breast cancer-free surgery within 4 weeks before enrollment, or the patient has not fully recovered from such surgery; 6. Severe heart disease or discomfort, including but not limited to the following:

    --A history of diagnosis of heart failure or systolic dysfunction (LVEF <50%)

  • High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate> 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular block (ie Mobitz II second-degree atrioventricular block or third-degree atrioventricular block)

    --Angina pectoris requiring antianginal medication

  • Clinically significant heart valve disease

    --ECG shows transmural myocardial infarction

  • Poorly controlled hypertension (systolic blood pressure> 180 mmHg and / or diastolic blood pressure> 100 mmHg); 7. Have an autoimmune disease or other disease that requires systemic treatment with corticosteroids or immunosuppressive drugs (physical corticosteroid replacement therapy that allows adrenal or pituitary insufficiency); 8. A history of primary or acquired immunodeficiency (including allograft transplantation); 9. Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraception during the entire trial and within 7 months after the last study medication; 10. have a history of (non-infectious) pneumonia, or currently have pneumonia that requires steroid therapy; 11. Active or previously documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis); 12. Known medical history of the following infections:

    • Human Immunodeficiency Virus (HIV)
    • A history of acute or chronic hepatitis B or C
  • Received live virus vaccine within 30 days of planned start of treatment. Allow use of seasonal influenza vaccines that do not contain live viruses; 13. People with a known history of allergies to the drug components of this program; a history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 14. Suffering from a serious concomitant disease or other comorbid condition that interferes with the planned treatment, or any other condition that the investigator considers the patient unsuitable to participate in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SHR-1210+Albumin-bound paclitaxel+Epirubicin

    Arm Description

    Neoadjuvant therapy:SHR-1210+Albumin-bound paclitaxel+Epirubicin

    Outcomes

    Primary Outcome Measures

    Pathological Complete Response (pCR)
    TpCR (ypT0 / is, ypN0) assessed by pathologists participating in the research center: defined as the pathological evaluation of hematoxylin and eosin-stained resected breast cancer samples and all ipsilateral lymph node samples after neoadjuvant therapy and surgery there is any residual invasive cancer.

    Secondary Outcome Measures

    Disease-free survival (DFS)
    Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death Defined as the time interval from the first day of disease-free (ie, the date of surgery) to the first recording of related events, which include recurrence of postoperative disease and death from any cause
    Objective Response Rate (ORR)
    CR+PR

    Full Information

    First Posted
    December 27, 2019
    Last Updated
    December 27, 2019
    Sponsor
    Henan Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04213898
    Brief Title
    SHR-1210 Combined With Albumin-bound Paclitaxel and Epirubicin Neoadjuvant for Triple Negative Breast Cancer
    Official Title
    SHR-1210 Combined With Albumin-bound Paclitaxel and Epirubicin Neoadjuvant for Triple Negative Breast Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2020 (Anticipated)
    Primary Completion Date
    January 2021 (Anticipated)
    Study Completion Date
    January 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Henan Cancer Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    Triple negative breast cancer (TNBC), characterized by estrogen receptor, progesterone receptor and HER2 negative, accounts for 10-20% of all breast cancers and usually occurs in young women. It is an aggressive and worst prognosis breast cancer subtype, which urgently requires effective treatment.The pathological complete response (pCR) of neoadjuvant therapy is associated with disease-free survival (DFS) and overall survival (OS) of breast cancer. The correlation between pathological response and long-term survival in patients with early-stage breast cancer is the strongest among patients with triple-negative breast cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Triple-negative Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    39 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SHR-1210+Albumin-bound paclitaxel+Epirubicin
    Arm Type
    Experimental
    Arm Description
    Neoadjuvant therapy:SHR-1210+Albumin-bound paclitaxel+Epirubicin
    Intervention Type
    Drug
    Intervention Name(s)
    SHR-1210+Albumin-bound paclitaxel + epirubicin
    Other Intervention Name(s)
    camrelizumab for injection
    Intervention Description
    Neoadjuvant therapy:SHR-1210, 200mg,iv, q3w, for 6 cycles; Albumin-bound paclitaxel: 125 mg/m2, iv, d1, d8, and d15, 21 days as a cycle, for 6 cycles; Epirubicin: 75mg / m2, iv, d1, 21 days as a cycle, for 6 cycles; The surgery was performed 3-4 weeks after the completion of neoadjuvant chemotherapy.
    Primary Outcome Measure Information:
    Title
    Pathological Complete Response (pCR)
    Description
    TpCR (ypT0 / is, ypN0) assessed by pathologists participating in the research center: defined as the pathological evaluation of hematoxylin and eosin-stained resected breast cancer samples and all ipsilateral lymph node samples after neoadjuvant therapy and surgery there is any residual invasive cancer.
    Time Frame
    At time of surgery
    Secondary Outcome Measure Information:
    Title
    Disease-free survival (DFS)
    Description
    Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death Time after R0 resection to disease recurrence or death Defined as the time interval from the first day of disease-free (ie, the date of surgery) to the first recording of related events, which include recurrence of postoperative disease and death from any cause
    Time Frame
    up to 2 year
    Title
    Objective Response Rate (ORR)
    Description
    CR+PR
    Time Frame
    up to 1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1. Newly treated female patients aged ≥18 years and ≤60 years; 2. ECOG score 0 ~ 1 points; 3. Pathologically confirmed, the core biopsy of breast tumor lesions identified patients with TNBC breast cancer; Note: ER and PR negatives are defined as ≤ 10% of cells expressing hormone receptors by IHC (immunohistochemistry) analysis. HER2 (human epidermal growth factor receptor 2) negative is defined as any of the following assessments: non-amplified in situ hybridization (ISH) (ratio ≤ 2.2), or IHC 0 or IHC 1+; 4. Evaluate measurable tumor lesions by ultrasound or magnetic resonance imaging (MRI) within 21 days before enrollment, size ≥2cm; 5. The main organs function normally, that is, they meet the following criteria: Blood routine examination standards must meet: ANC ≥1.5 × 109 / L; PLT ≥90 × 109 / L; Hb ≥90g / L; Biochemical examination must meet the following standards: TBIL ≤ upper limit of normal value (ULN); ALT and AST ≤ 1.5 times the upper limit of normal value (ULN); alkaline phosphatase ≤ 2.5 times the upper limit of normal value (ULN); BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥50 mL / min (CockcroftGault formula); The coagulation test standard must meet: the international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN, and the activated partial thromboplastin time (aPTT) ≤ 1.5x ULN; Color Doppler ultrasound and echocardiography: left ventricular ejection fraction (LVEF≥55%); 18-lead electrocardiogram Fridericia-corrected QT interval (QTcF) for women <470 ms; 6. No evidence of distant metastases, including bilateral mammograms, breast ultrasounds; 7. Provide core biopsies from tumor lesions before treatment begins to confirm TNBC status and biomarker analysis; 8. For women who are not menopausal or not undergoing surgical sterilization: agree to abstinence or use an effective method of contraception during treatment and at least 7 months after the last dose during study treatment; 9. Sign the informed consent. Exclusion Criteria: 1. Inflammatory breast cancer or stage IV (metastatic) breast cancer; 2. Have previously been treated with anti-PD-1, anti-PD-L1, anti-PD-L2 drugs or drugs that target another co-inhibitory T cell receptor (eg CTLA-4, OX-40, CD137); 3. Have previously received antitumor treatment or radiation therapy for any malignant tumor, excluding cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; 4. Also receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphate therapy or immunotherapy; 5. Have undergone major breast cancer-free surgery within 4 weeks before enrollment, or the patient has not fully recovered from such surgery; 6. Severe heart disease or discomfort, including but not limited to the following: --A history of diagnosis of heart failure or systolic dysfunction (LVEF <50%) High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate> 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-level atrioventricular block (ie Mobitz II second-degree atrioventricular block or third-degree atrioventricular block) --Angina pectoris requiring antianginal medication Clinically significant heart valve disease --ECG shows transmural myocardial infarction Poorly controlled hypertension (systolic blood pressure> 180 mmHg and / or diastolic blood pressure> 100 mmHg); 7. Have an autoimmune disease or other disease that requires systemic treatment with corticosteroids or immunosuppressive drugs (physical corticosteroid replacement therapy that allows adrenal or pituitary insufficiency); 8. A history of primary or acquired immunodeficiency (including allograft transplantation); 9. Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraception during the entire trial and within 7 months after the last study medication; 10. have a history of (non-infectious) pneumonia, or currently have pneumonia that requires steroid therapy; 11. Active or previously documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis); 12. Known medical history of the following infections: Human Immunodeficiency Virus (HIV) A history of acute or chronic hepatitis B or C Received live virus vaccine within 30 days of planned start of treatment. Allow use of seasonal influenza vaccines that do not contain live viruses; 13. People with a known history of allergies to the drug components of this program; a history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 14. Suffering from a serious concomitant disease or other comorbid condition that interferes with the planned treatment, or any other condition that the investigator considers the patient unsuitable to participate in this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chengzheng Wang
    Phone
    13803711526
    Email
    13724085853@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    SHR-1210 Combined With Albumin-bound Paclitaxel and Epirubicin Neoadjuvant for Triple Negative Breast Cancer

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