Patients with HER2-positive, ER/PR-positive breast cancer scheduled for neoadjuvant therapy, with clinical stage II–III.HER2-positive: HER2 IHC 3+ or IHC 2+ with ISH positivity
Conditions
Interventions
Trial group:Neratinib: 120 mg/d (Days 1-7), 160 mg/d (Days 8-14), 240 mg/d (Days 15-140), once daily with meals
Trastuzumab: initial loading dose of 8 mg/kg, followed by 6 mg/kg every 3 weeks for 6 cycles
Fulvestrant: 500 mg once monthly, with a second 500 mg dose required two weeks after the first dose, for a total of 5 cycles.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged >=18 years and =10%); 6. Adequate organ function (no transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor [CSF] administered within 14 days before the first study drug): ? Hematologic function: Absolute neutrophil count (ANC) >=1.5×10^9/L; platelet count (PLT) >=100×10^9/L; hemoglobin (Hb) >=90 g/L; ? Hepatic function: Total bilirubin (TBIL) =50 mL/min (calculated by the Cockcroft-Gault formula); ? Coagulation function: Prothrombin time (PT) and activated partial thromboplastin time (APTT) =55% on echocardiography; 7. Negative serum pregnancy test for women of childbearing potential. Highly effective contraception must be used during the study and for 180 days after the last dose of study drug; 8. Voluntary participation in the clinical study and signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. History of tumor-related diseases and prior anti-tumor treatment; 2. Known hypersensitivity to the study drug or any of its excipients; 3. Local recurrence or metastasis detected by clinical or imaging examinations before or at study initiation; 4. Patients who participated in, are participating in, or intend to participate in other interventional clinical trials within 4 weeks prior to enrollment; 5. Patients who received the study drug within 14 days before starting treatment; 6. Patients currently receiving chemotherapy, radiotherapy, immunotherapy, or biological therapy for breast cancer; 7. Patients with severe psychiatric disorders who are unable to provide informed consent, comply with treatment, or complete follow-up; 8. Pregnant or lactating women, or women planning to conceive in the near future; 9. Patients judged by the investigator to be ineligible for this study due to serious underlying diseases, abnormal laboratory test results, or other reasons; 10. Patients unable to swallow medications orally.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator-assessed total pathological complete response (tpCR) rate (ypT0/is, ypN0); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) assessed by RECIST v1.1 preoperatively;Breast pathological complete response (bpCR) rate (ypT0/is);Proportion of patients with Residual Cancer Burden (RCB) score 0/1;Change in Ki67 expression from baseline to surgery; | — |
Countries
China
Contacts
Public ContactZhu Li
Shanghai General Hospital
Outcome results
None listed