Breast cancer
Conditions
Interventions
Pyrotinib Combined with Dalpiciclib and Standard Endocrine Therapy:Pyrotinib Combined with Dalpiciclib and Standard Endocrine Therapy
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients must meet all of the following inclusion criteria to enroll in this study:1.Age: Female patients aged >=18 and =10%) and HER2-low expression (IHC 2+ with negative FISH). 3.Invasive breast cancer eligible for neoadjuvant therapy (T >=3 cm and/or N >=1, as per pathological assessment). 4.ECOG performance status: 0–1. 5.Planned definitive breast cancer surgery (breast-conserving surgery or mastectomy) with sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND). 6.Adequate organ function, defined as:(1)Hematological:ANC >=1.5 × 10^9/L,Platelets >=90 × 10^9/L,Hemoglobin >=90 g/L.(2)Biochemical:Total bilirubin =50 mL/min (Cockcroft-Gault formula).(3)Cardiac function:Left ventricular ejection fraction (LVEF) >=55% by echocardiogram,QTcF interval <470 ms (Fridericia correction, 12-lead ECG). 7.For premenopausal or non-sterilized female patients: Agreement to use highly effective contraception ormaintain abstinence during treatment and for at least 7 months after the last dose. 8.Voluntary participation: Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients meeting any of the following criteria will be excluded from the study:1.Known hypersensitivity to any component of the study drugs 2.Prior anticancer therapy or radiotherapy for any malignancy (except cured carcinoma in situ of the cervix or basal cell carcinoma) 3.Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or incomplete recovery from such procedures 4.Stage IV (metastatic) breast cancer 5.Inability to swallow, intestinal obstruction, or other conditions affecting drug administration and absorption 6.Severe cardiac disease or conditions precluding safe treatment 7.Active psychiatric disorders or substance abuse compromising protocol compliance 8.Pregnant or lactating women 9.Severe hepatic/renal dysfunction or hematologic disorders 10.Other conditions deemed ineligible by investigators, including:History of substance abuse,Use of blood products, anticoagulants, or immunomodulators within the past year,Poor compliance or refusal to cooperate with treatment,Uncontrolled hypertension or diabetes mellitus,Any condition considered to jeopardize study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactChen Shuanglong
The First Affiliated Hospital of Xiamen University
Outcome results
None listed