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

NCT ID: NCT05491694

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-12-30

Brief 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.

Conditions

Breast Cancer; TNBC - Triple-Negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HIFU+Toripalimab+Chemotherapy

High Intensity Focused Ultrasoun， followed by Toripalimab 240 mg + epirubicin 90 mg/m2 + cyclophosphamide 600 mg/m2 × 4 cycles → Toripalimab240 mg + carboplatin AUC 5 + nab-paclitaxel 260 mg/m2 IVD × 4 cycles every 3 weeks for 8 doses.

Group Type: EXPERIMENTAL

Toripalimab

Intervention Type: DRUG

Toripalimab 240mg

Epirubicin

Intervention Type: DRUG

90mg/m2，IVD，q3w

High Intensity Focused Ultrasoun

Intervention Type: PROCEDURE

HIFU treatment at lesion site

Cyclophosphamide

Intervention Type: DRUG

600mg/m2，IVD，q3w

Carboplatin

Intervention Type: DRUG

AUC 5，IVD，q3w

Nab-paclitaxel

Intervention Type: DRUG

260mg/m2，IVD，q3w

Interventions

Toripalimab

Toripalimab 240mg

Intervention Type: DRUG

Epirubicin

90mg/m2，IVD，q3w

Intervention Type: DRUG

High Intensity Focused Ultrasoun

HIFU treatment at lesion site

Intervention Type: PROCEDURE

Cyclophosphamide

600mg/m2，IVD，q3w

Intervention Type: DRUG

Carboplatin

AUC 5，IVD，q3w

Intervention Type: DRUG

Nab-paclitaxel

260mg/m2，IVD，q3w

Intervention Type: DRUG

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.

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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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shui Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

HIFU202207

Identifier Type: -

Identifier Source: org_study_id