HR-positive HER2-positive early-stage breast cancer (i.e. triple-positive breast cancer, defined as breast cancer with positive expression of the oestrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2))
Conditions
Interventions
Trial group:Pyrotinib (400 mg orally, once daily) is added to the TCHP regimen, with all other drugs administered at the same doses and cycles as the control group. Administration method: Intravenous
Control group:Continue the TCHP regimen (docetaxel 75 mg/m2 + carboplatin AUC 5 + trastuzumab 6 mg/kg + pertuzumab 420 mg), with one cycle every 21 days for a total of 4 cycles, followed by surgery. A
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Participants voluntarily enrolled in this study, signed informed consent forms, and demonstrated good compliance. 2.Age: 18 to 75 years old (at the time of signing the informed consent form); ECOG Performance Status: 0 to 1. 3.Pathological testing confirmed the diagnosis of HR-positive HER2-positive invasive breast cancer. 4.HR-positive is defined as follows: the number of positive cells for ER or PR in immunohistochemical staining reaches or exceeds 1%, which can be judged as HR HER2 positivity is defined as 3+ by standard immunohistochemistry (IHC); if 2+, in situ hybridisation (ISH) must be performed to confirm positivity or ISH only. 5.Early breast cancer (cT1-3 or N0-1/M0) or locally advanced breast cancer (cT4N2-3M0) by clinical assessment. 6.Clear ER/PR and Ki67 status is required before neoadjuvant chemotherapy. 7.Good major organ function and adequate cardiac function requiring a baseline left ventricular ejection fraction (LVEF) of 55% or greater as measured by echocardiography and Fridericia-corrected QT (QTcF) interval of less than 470 ms. 8.Female subjects of childbearing potential should agree that they must use contraception (e.g., intrauterine devices, birth control pills, or condoms) during the study and for 6 months after study completion; have a negative serum pregnancy test within 7 days prior to study entry, and must be non-lactating subjects..
Exclusion criteria
Exclusion criteria: 1.Bilateral breast cancer, occult breast cancer, inflammatory breast cancer, metastatic/recurrent breast cancer. 2.Have not received any systemic therapy or radiation therapy in the past. 3.Have not received any other malignant tumour in the past 5 years. 4.Have a history of live attenuated vaccination in the 28 days prior to the enrolment or plan to undergo live attenuated vaccination during the study period. 5.Participated in a clinical trial of other anti-tumour drugs in the 4 weeks prior to the enrolment. 6.Have other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participation in the study or interfere with the study results, as well as other reasons considered by the investigator to be inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathologic complete remission rate (tpCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast primary lesion pCR(bpCR);Distant Disease-Free Survival (DDFS);Disease-free survival (DFS);Objective remission rate (ORR);Biomarkers (Ki67, PAM50, HER2DX, etc.);Safety indicators (incidence and severity of adverse events);Event-free survival (EFS); | — |
Countries
China
Contacts
Public ContactWang Ke
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed