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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05491694

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer TNBC - Triple-Negative Breast Cancer	Drug: Toripalimab Drug: Epirubicin Procedure: High Intensity Focused Ultrasoun Drug: Cyclophosphamide Drug: Carboplatin Drug: Nab-paclitaxel	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

To Evaluate the Efficacy and Safety of Toripalimab Combined With Chemotherapy (Epirubicin + Cyclophosphamide → Nab-paclitaxel + Carboplatin) in the Neoadjuvant Treatment of Triple-negative Breast Cancer After High-intensity Focused Ultrasound (HIFU) Induction

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Toripalimab Toripalimab 240mg Drug: Epirubicin 90mg/m2，IVD，q3w Procedure: High Intensity Focused Ultrasoun HIFU treatment at lesion site Drug: Cyclophosphamide 600mg/m2，IVD，q3w Drug: Carboplatin AUC 5，IVD，q3w Drug: Nab-paclitaxel 260mg/m2，IVD，q3w

Arm

Intervention/Treatment

Experimental: 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.

Drug: Toripalimab

Toripalimab 240mg

Drug: Epirubicin

90mg/m2，IVD，q3w

Procedure: High Intensity Focused Ultrasoun

HIFU treatment at lesion site

Drug: Cyclophosphamide

600mg/m2，IVD，q3w

Drug: Carboplatin

AUC 5，IVD，q3w

Drug: Nab-paclitaxel

260mg/m2，IVD，q3w

Outcome Measures

Primary Outcome Measures

pCR [6 months]
Pathologic complete response rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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;
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%);
triple-negative breast cancer patients without distant metastasis;
According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, they have at least one evaluable target lesion;
ECOG PS score: 0 - 1;
New York Heart Association (NYHA) functional class I;
Electrocardiogram without myocardial ischemia, echocardiography LVEF > 55%, cardiac markers: cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) test values within the normal range;
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;

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:

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;
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.;
Known allergy to the active ingredients or other components of the study drug or surgical contraindications;
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;
Severe liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease or uncontrolled diabetes, active gastrointestinal ulcers and other need treatment;
Need to receive other anti-tumor therapy (except ovarian function inhibitors) during neoadjuvant therapy as judged by the investigator;
Patients who are participating in other clinical trials within one month;
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;
any other condition that in the opinion of the investigator would make the patient inappropriate for participation in this study.