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

Breast Cancer Clinical Trial

— HIFU  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05491694
• Other study ID #: HIFU202207
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2022
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• TNBC - Triple-Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Toripalimab
Toripalimab 240mg
• Epirubicin
90mg/m2,IVD,q3w

Procedure:
• High Intensity Focused Ultrasoun
HIFU treatment at lesion site

Drug:
• Cyclophosphamide
600mg/m2,IVD,q3w
• Carboplatin
AUC 5,IVD,q3w
• Nab-paclitaxel
260mg/m2,IVD,q3w

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pCR	Pathologic complete response rate	6 months