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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