Breast Cancer, HR+/HER2- Breast Cancer
Conditions
Keywords
HR+/HER2- early breast cancer, HIFU, Immunotherapy, Neoadjuvant therapy
Brief summary
To explore the efficacy and safety of adebrelimab combined with chemotherapy (epirubicin + cyclophosphamide →docetaxel) neoadjuvant therapy early HR+/HER2- breast cancer with high risk factors after the induction treatment of HIFU and adebrelimab.
Interventions
DRUGAdebrelimab
Adebrelimab 1200mg iv q3w
PROCEDUREHigh Intensity Focused Ultrasoun（HIFU）
HIFU treatment at lesion site
DRUGCyclophosphamide
600mg/m2 iv q3w
DRUGEpirubicin
90mg/m2 iv q3w
DRUGDocetaxel
75mg/m2 iv q3w
Sponsors
Jiangsu Hengrui Pharmaceutical Co., Ltd.
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 with hormone receptor- positive, which defined as estrogen receptor (ER) ≥ 1%, and/ or progesterone receptor (PR) ≥ 1%, and HER-2 (0 or +), or ++,but FISH is no amplification; 3. Tumor size ≥ 3cm, and histological grade is 3 (poorly differentiated); 4. Regardless of lymph node status, but without distant metastasis; 5. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, they have at least one evaluable target lesion; 6. ECOG PS score: 0 - 1; 7. New York Heart Association (NYHA) functional class I; 8. Electrocardiogram without myocardial ischemia, echocardiography LVEF \> 55%, cardiac markers: cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) test values within the normal range; 9. 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 conditions that in the opinion of the investigator would make the patient inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tpCR | 6 months | total pathologic complete response rate（lymph node and breast） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bpCR | 6 months | breast pathologic complete response rate |
Contacts
Primary ContactWenbin Zhou, Professor
Outcome results
None listed