Status:
NOT_YET_RECRUITING
The Neoadjuvant Treatment of Early High-risk Triple Negative Breast Cancer With HRD Positive With Iparomlimab and Tuvonralimab Combined With Olaparib and Paclitaxel
Lead Sponsor:
Harbin Medical University
Conditions:
Triple Negative Breast Cancer (TNBC)
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
Breast cancer is one of the most common malignant tumors in women, accounting for the first cancer-related death cause in women. In recent years, the incidence has gradually increased, and the trend i...
Eligibility Criteria
Inclusion
- Voluntarily join this study and sign an informed consent form;
- Women aged ≥ 18 years and ≤ 70 years with early breast cancer:According to the definition of the latest ASCO/CAP guidelines, triple negative breast cancer patients with T1cN1-2 or T2-4N0-2 stage confirmed by histopathology;
- Subjects with HRD positive tumor tissue evaluation;
- According to RECIST 1.1, there must be at least one measurable lesion;
- ECOG score: 0 to 1;
- Tumor tissue specimens that can be used for biomarker detection;
- The function of important organs meets the following requirements (no blood components or cell growth factor drugs are allowed to be used within 14 days before the first medication):
- Absolute neutrophil count ≥ 1.5 × 10\^9/L; Platelets ≥ 100 × 10\^9/L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group); Serum total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; AKP≤ 2.5×ULN； Serum creatinine ≤ 1.5 × ULN;
- Female patients with non-surgical sterilization or childbearing age need to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill or condom) during the study treatment period and within 3 months after the end of the study treatment period; ; And must be non lactation; For male patients whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 3 months after the last administration of trial drugs.
Exclusion
- There is any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo or asthma in childhood have been completely relieved and do not need any intervention after adulthood can be included; asthma requiring medical intervention with bronchodilators cannot be included);
- Currently using immunosuppressants or systemic hormone therapy for immunosuppression (with a dosage of \>10mg/day of prednisone or other equally effective hormones), and still continuing to use them within 2 weeks prior to enrollment;
- Severe allergic reaction to other monoclonal antibodies;
- Known history or evidence of interstitial lung disease or active non infectious pneumonia;
- Having other malignant tumors in the past 5 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ);
- Have hypertension and can not be well controlled after antihypertensive drug treatment; Had hypertension crisis or hypertensive encephalopathy in the past;
- There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure above NYHA grade 2 (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention (5) qtc\>450ms (male); Qtc\>470ms (female);
- The urine routine showed that the urine protein was ≥ + +, and the 24-hour urine protein volume was confirmed to be \>1.0 g;
- Patients with active infection, unexplained fever ≥ 38.5 ℃ within 7 days before medication, or white blood cell count \>15 × 10\^9/l at baseline;
- Have congenital or acquired immune deficiency (such as HIV infected persons); Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 iu/ml, or hepatitis C virus antibody positive;
- Less than 4 weeks before the study medication or may be vaccinated with live vaccines during the study period;
- Bilateral breast cancer;
- According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the patient.
Key Trial Info
Start Date :
December 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07187674
Start Date
December 30 2025
End Date
December 31 2028
Last Update
September 23 2025
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