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

SHR-1210 Combined With Albumin-bound Paclitaxel and Epirubicin Neoadjuvant for Triple Negative Breast Cancer: Condition:   Triple-negative Breast Cancer Intervention:   Drug: SHR-1210+Albumin-bound paclitaxel + epirubicin Sponsor:   Henan Cancer Hospital Not yet recruiting (Source: ClinicalTrials.gov)




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SHR-1210 Combined With Albumin-bound Paclitaxel and Epirubicin Neoadjuvant for 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: NCT04213898

Recruitment Status  : Not yet recruiting

First Posted  : December 30, 2019

Last Update Posted  : December 30, 2019

See Contacts and Locations

Sponsor:

Henan Cancer Hospital

Information provided by (Responsible Party):

Wachengzheng, Henan Cancer Hospital



Study DetailsTabular ViewNo Results PostedDisclaimerHow to Read a Study Record

Study Description

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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.



Condition or disease Intervention/treatment Phase

Triple-negative Breast Cancer

Drug: SHR-1210+Albumin-bound paclitaxel + epirubicin

Phase 1

Phase 2



Study Design

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Study Type  : Interventional  (Clinical Trial)

Estimated Enrollment  : 39 participants

Intervention Model: Single Group Assignment

Masking: None (Open Label)

Primary Purpose: Treatment

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

Estimated Study Start Date  : January 2020

Estimated Primary Completion Date  : January 2021

Estimated Study Completion Date  : January 2023

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Paclitaxel Epirubicin hydrochloride Epirubicin

U.S. FDA Resources



Arms and Interventions

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Arm Intervention/treatment

Experimental: SHR-1210+Albumin-bound paclitaxel+Epirubicin

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

Drug: SHR-1210+Albumin-bound paclitaxel + epirubicin

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.

Other Name: camrelizumab for injection







Outcome Measures

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Primary Outcome Measures  :

Pathological Complete Response (pCR) [ Time Frame: At time of surgery ]

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 Frame: up to 2 year ]

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) [ Time Frame: up to 1 year ]

CR+PR





Eligibility Criteria

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Information from the National Library of Medicine

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Ages Eligible for Study:  18 Years to 60 Years   (Adult)

Sexes Eligible for Study:  Female

Accepts Healthy Volunteers:  No

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.

Contacts and Locations

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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): NCT04213898





Contacts

Contact: Chengzheng Wang 13803711526 13724085853@163.com



Sponsors and Collaborators

Henan Cancer Hospital

More Information

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Responsible Party: Wachengzheng, Doctor, Henan Cancer Hospital

ClinicalTrials.gov Identifier: NCT04213898     History of Changes

Other Study ID Numbers: HR-TNBC-HN100

First Posted: December 30, 2019    Key Record Dates

Last Update Posted: December 30, 2019

Last Verified: December 2019

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

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

Additional relevant MeSH terms:

Breast Neoplasms

Triple Negative Breast Neoplasms

Neoplasms by Site

Neoplasms

Breast Diseases

Skin Diseases

Paclitaxel

Albumin-Bound Paclitaxel

Epirubicin

Antineoplastic Agents, Phytogenic

Antineoplastic Agents

Tubulin Modulators

Antimitotic Agents

Mitosis Modulators

Molecular Mechanisms of Pharmacological Action

Antibiotics, Antineoplastic

Topoisomerase II Inhibitors

Topoisomerase Inhibitors

Enzyme Inhibitors





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