Breast cancer
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab(QL1706) in Combination with Trastuzumab, Pertuzumab, and Nab-Paclitaxel
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years (inclusive). 2. Histologically confirmed unilateral invasive breast carcinoma with primary tumour diameter > 2 cm as determined by locally accepted assessment methods. 3.Disease stage according to AJCC 8th edition: early-stage (T2–T3, N0–N1, M0) or locally advanced (T2–T3, N2 or N3, M0; T4, any N, M0). 4.HER2-positive status confirmed by molecular pathology (immunohistochemistry 3+ or 2+ with concurrent fluorescence in situ hybridisation-positive). 5 . Known oestrogen-receptor (ER) and progesterone-receptor (PgR) status. 6. Available tumour tissue adequate for biomarker analyses. 7. At least one measurable lesion by RECIST 1.1 on CT or MRI; bone-only lesions are considered non-measurable and disqualify the patient. 8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 9 . Any PD-L1 expression status is permitted. 1 0.Adequate organ function as specified below (no transfusion of blood products or growth factors within 14 days before first study dose): • Absolute neutrophil count >= 1.5 × 10^9/L • Platelets >= 100 × 10^9/L • Haemoglobin >= 90 g/L • Serum albumin >= 30 g/L • Thyroid-stimulating hormone (TSH) = 55 % at baseline by echocardiography (preferred) or multigated acquisition (MUGA) scan. 11. Women of child-bearing potential (WOCBP) who are not surgically sterile must use a medically acceptable contraceptive method (e.g., intrauterine device, oral contraceptive, condom) from study entry until 7 months after the last dose of study treatment. WOCBP must have a negative serum or urine ß-hCG test within 7 days before the first study dose and must not be breastfeeding. Men with partners of child-bearing potential must use effective contraception from study entry until 3 months after the last dose. 12. Provide written informed consent, understand the nature, objectives, and procedures of the study, and agree to comply with all protocol requirements.
Exclusion criteria
Exclusion criteria: 1. Evidence of bilateral breast cancer or metastatic disease (M1); 2.HER2-negative patients, defined as immunohistochemistry (IHC) 0- 1+, or IHC 2+ with negative in situ hybridization (ISH) or absence of HER2 amplification; 3. History of severe hypersensitivity reactions to other monoclonal antibodies; 4. Prior treatment with any investigational agents for malignancy, including radiotherapy, chemotherapy, surgery (excluding biopsy), targeted therapy, and anti-PD-1/CTLA-4 antibody therapy; 5.Presence of any active autoimmune disease or history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Note: Patients with vitiligo, childhood asthma in complete remission without intervention in adulthood, or asthma controlled only with bronchodilators are excluded); 6.Current use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes (>10mg/day prednisone or equivalent) within 2 weeks before or to enrollment; 7. Known history or evidence of interstitial lung disease (ILD) or active non-infectious pneumonitis; 8.History of prior malignancies (*except: patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible; patients with other prior malignancies must be disease-free for >= 3 years*); 9.Uncontrolled hypertension despite antihypertensive therapy (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg) (Note: Antihypertensive treatment is permitted; history of hypertensive crisis or hypertensive encephalopathy is excluded); 10.Known history within 6 months before the first dose of unstable angina, myocardial infarction (MI), chronic heart failure (CHF), clinically significant arrhythmias requiring antiarrhythmic treatment (excluding stable atrial fibrillation), or left ventricular ejection fraction (LVEF) = ++ with confirmed 24-hour urinary protein >1.0 g; 17. Active infection, unexplained fever >= 38.5°C within 7 days before medication, or baseline white blood cell count >15×10^9/L; 18. Known congenital or acquired immunodeficiency (e.g., HIV infection); Hepatitis B surface antigen (HBsAg) positivity with HBV DNA >= 2000 IU/mL, or hepatitis C virus (HCV) antibody positivity; 19. Any condition that, in the investigator's judgment, may affect study results or lead to premature study termination (including alcohol/drug abuse, other severe comorbidities [including psychiatric disorders] requiring concomitant therapy, severe laboratory abnormalities, or social/family factors compromising patient safety); 20.Pregnant or lactatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Pathological Complete Response (tpCR) Rate;Serious adverse events (SAEs);Treatment-related adverse events (TRAEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response reate (ORR);Surgical Resection Rate;Adverse events (AE); | — |
Countries
China
Contacts
Public ContactHaibo Wang
The Affiliated Hospital of Qingdao University
Outcome results
None listed