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Trial Title: To Evaluate the Efficacy of Toripalimab Combined With Chemotherapy After HIFU Induction in the Treatment of Early Triple-negative Breast Cancer

NCT ID: NCT05491694

Condition: Breast Cancer
TNBC - Triple-Negative Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Cyclophosphamide
Carboplatin
Epirubicin

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Toripalimab
Description: Toripalimab 240mg
Arm group label: HIFU+Toripalimab+Chemotherapy

Intervention type: Drug
Intervention name: Epirubicin
Description: 90mg/m2,IVD,q3w
Arm group label: HIFU+Toripalimab+Chemotherapy

Intervention type: Procedure
Intervention name: High Intensity Focused Ultrasoun
Description: HIFU treatment at lesion site
Arm group label: HIFU+Toripalimab+Chemotherapy

Intervention type: Drug
Intervention name: Cyclophosphamide
Description: 600mg/m2,IVD,q3w
Arm group label: HIFU+Toripalimab+Chemotherapy

Intervention type: Drug
Intervention name: Carboplatin
Description: AUC 5,IVD,q3w
Arm group label: HIFU+Toripalimab+Chemotherapy

Intervention type: Drug
Intervention name: Nab-paclitaxel
Description: 260mg/m2,IVD,q3w
Arm group label: HIFU+Toripalimab+Chemotherapy

Summary: To investigate the efficacy and safety of terbinumab combined with chemotherapy (epirubicin + cyclophosphamide → nab-paclitaxel + carboplatin) in neoadjuvant therapy of triple-negative breast cancer after HIFU.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Female patients aged ≥ 18 years who require a negative pregnancy test for premenopausal and perimenopausal patients and promise to take reliable contraceptive measures during treatment; 2. Histopathologically confirmed breast cancer patients who are negative for estrogen receptor (ER), progesterone receptor (PR), and HER-2 by immunohistochemistry; positive PD-L1 expression in tumor cells (≥ 1%); 3. triple-negative breast cancer patients without distant metastasis; 4. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, they have at least one evaluable target lesion; 5. ECOG PS score: 0 - 1; 6. New York Heart Association (NYHA) functional class I; 7. Electrocardiogram without myocardial ischemia, echocardiography LVEF > 55%, cardiac markers: cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) test values within the normal range; 8. Normal major organ function, Meet the following criteria: WBC ≥ 4.0 × 10 9/L,Neutrophil count (ANC) ≥ 1.5 × 10 9/L; platelet ≥ 100 × 10 9/L; hemoglobin ≥ 10 g/dL; serum creatinine ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) ≤ 2.5 × ULN; alanine aminotransferase (ALT) ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; serum creatinine ≤ 1.5 × ULN; 9) The subject is able to understand the study procedures, voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with the follow-up. - Exclusion Criteria: 1. Patients during pregnancy and lactation, women of childbearing age who refuse to take effective contraceptive measures during the study period; Patients with peripheral nervous system disorders caused by diseases or those with a history of significant mental disorders and central nervous system disorders; 2. Serious or uncontrolled infections that may affect the evaluation of study treatment or study results, including but not limited to: active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc.; 3. Known allergy to the active ingredients or other components of the study drug or surgical contraindications; 4. In addition to cured basal cell carcinoma of the skin and cured cervical carcinoma in situ, other cancers are disease-free for less than 5 years; 5. Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, active gastrointestinal ulcers and other need treatment; 6. Need to receive other anti-tumor therapy (except ovarian function inhibitors) during neoadjuvant therapy as judged by the investigator; 7. Patients who are participating in other clinical trials within one month; 8. Patients with severe heart disease or discomfort, Expected intolerance to chemotherapy,Including, but not limited to: a. fatal arrhythmia or higher grade atrioventricular block (second-degree type 2 [Mobitz 2] atrioventricular block or third-degree atrioventricular block); b. unstable angina pectoris; c. clinically significant valvular heart disease; d. transmural myocardial infarction on electrocardiogram; e. uncontrolled hypertension; 9. any other condition that in the opinion of the investigator would make the patient inappropriate for participation in this study.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: September 1, 2022

Completion date: December 30, 2024

Lead sponsor:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Source: The First Affiliated Hospital with Nanjing Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05491694

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