Clinical trial · Interventional
To Evaluate the Efficacy of Adebrelimab Combined With Chemotherapy After HIFU Induction Neoadjuvant Therapy HR+/HER2- Breast Cancer
To Evaluate the Efficacy and Safety of Adebrelimab Combined With Chemotherapy Neoadjuvant Therapy in Early or Local Advanced Breast Cancer After Induction Treatment of High-intensity Focused Ultrasound and Adebrelimab
NCT06470633CI-TRIAL-00078172not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| HR+/HER2- Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| High Intensity Focused Ultrasoun(HIFU) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HIFU+Adebrelimab+Chemotherapy
- description
- Induction phase: HIFU+Adebrelimab Neoadjuvant Therapy phase: Adebrelimab+ EC-T(Epirubicin + Cyclophosphamide → Docetaxel
- interventionNames
- Drug: Adebrelimab
- Procedure: High Intensity Focused Ultrasoun(HIFU)
- Drug: Cyclophosphamide
- Drug: Epirubicin
- Drug: Docetaxel
Primary outcomes (1)
- measure
- tpCR
- timeFrame
- 6 months
- description
- total pathologic complete response rate(lymph node and breast)
Secondary outcomes (1)
- measure
- bpCR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.