Triple negative breast cancer
Conditions
Interventions
Experimental group:penpulimab+albumin paclitaxel+carboplatin
Sponsors
Chinese People's Liberation Army Army 958 Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1)Female aged 18-75 years old, expected survival time > 3 months; 2) Histopathology confirmed stage II or III triple-negative breast cancer (Specifically defined as: ER, PR negative: IHC detection ER=10%, PR =10%. IHC detection HER-2 0/1+ or HER-2 ++, and FISH detection negative, no amplification); 3)No previous definitive ipsilateral breast surgery for the current breast cancer. 4)No previous chemotherapy, endocrine therapy, or radiation therapy with therapeutic intent for this cancer. 5)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6) At least one objectively measurable lesion according to the RECIST 1.1 . 7) T>2cm, or N+; 8) The level of organ function must meet the following requirements: ? Blood routine: a. Hemoglobin (HB) = 90g/L b. Absolute value of neutrophils (ANC) = 1.5 × 10^9/L; c. Platelet (PLT) = 100 × 10^9/L; ? Blood biochemistry: a. Total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN); Or total bilirubin>ULN but direct bilirubin = ULN b. Alanine aminotransferase (ALT) and aspartate aminotransferase AST = 2.5 × ULN; c. Serum creatinine (Cr) = 1.5 × ULN or creatinine clearance rate (CCr) = 60ml/min; ? Cardiac ultrasound: Left ventricular ejection fraction (LVEF) = 50% ? 12-lead electrocardiogram: QT interval<480 ms. 9) Patients with negative serum pregnancy test and potential fertility must agree to use effective non-hormonal method of contraception during treatment and at least 6 months after the last dose of study treatment; 10) Volunteer to participate in this study and sign an informed consent form, and have good compliance and willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1) Has a history of invasive malignancy =5 years prior to signing informed consent except for adequately treated carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin. 2) Participant has metastatic breast cancer (stage IV). 3) Participant has inflammatory breast cancer. 4) Histopathological diagnosis of breast neuroendocrine carcinoma or metaplastic carcinoma. 5) Has received prior chemotherapy, radiation therapy, and targeted therapywithin the past 12 months. 6) Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4], OX-40, CD137). 7) While receiving any other anti-tumor therapy. 8) Participant who have participated in clinical trials of other drugs within 4 weeks 9) Subject has received a live vaccine within 30 days prior to the first dose of study drug. 10) Has active autoimmune disease that has required systemic treatment in the past 2 years (such as the use of disease regulating drugs, corticosteroids, or immunosuppressive drugs). 11) Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (daily dose exceeds 10 mg prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy. 12) Has a known history of Human Immunodeficiency Virus (HIV). 13) Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA copy number = 2000 IU/mL (HBsAg positive and hepatitis B virus DNA copy number < 2000 IU/mL need to receive anti-HBV treatment for at least 2 weeks before the first administration); Hepatitis C virus (HCV) antibody positive and HCV RNA positive. 14) Has a history of (non-infectious) pneumonitis that required steroids, or has current pneumonitis. 15) Has an active infection requiring systemic therapy. 16) Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV. 17) Has a known hypersensitivity to the components of the study treatment or its analogs. 18) Has a known history of active tuberculosis (TB, Bacillus Tuberculosis). 19)Pregnant and lactating women, fertile women with positive baseline pregnancy test or women of childbearing age who refused to take appropriate contraceptive measures during the whole trial period; 20) Have a definite history of neurological or psychiatric disorders, including epilepsy or dementia; 21) Any other condition in which the investigator considered the patient to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Pathologic Complete Response (tpCR:ypT0/Tis ypN0); | — |
Secondary
| Measure | Time frame |
|---|---|
| bpCR(breast pathologic Complete Response);apCR(axillary pathologic Complete Response);iDFS (Invasive Disease-Free Survival);OS (Overall Survival);Safety;EFS (Event Free Survival);ORR (Objective Response Rate); | — |
Countries
China
Contacts
Public ContactXiaowei Qi \ Kai You
Chinese People's Liberation Army Army 958 Hospital
Outcome results
None listed