Early or locally advanced HR-/HER2+ breast cancer
Conditions
Interventions
The insensitive group (tumor regression rate <40% after two cycles):Switch to the TCbHPy treatment regimen and continue until the end of six cycles
The sensitive group (tumor regression rate of =40% after two cycles):Continue with the original TCbHP treatment regimen until the end of the sixth cycle
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. For women aged 18 to 75, those who are premenopausal or in perimenopause require a negative pregnancy test result, and they must commit to using reliable contraception during treatment; 2. Pathological examination confirmed invasive breast cancer with HER2 positivity (immunohistochemical staining intensity of 3+ or 2+, and FISH indicating HER2 gene amplification). Breast cancer patients who were enrolled in the early stage (T2 to 3, N0 to 1, M0) or locally advanced stage (T2 to 3, N2 to 3, M0) and received Trastal dual-target neoadjuvant therapy were included; 3. According to the efficacy evaluation criteria for solid tumors (version 1.1), there must be at least one measurable lesion; 4. No previous breast cancer-related chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy; 5. ECOG performance status score of 0 or 1; 6. Sign the informed consent form; 7. The organ function is still good and meets the following criteria: hemoglobin >= 90 g/L, white blood cells >= 3.5 x 10^9/L, platelets >= 100 x 10^9/L, neutrophils >= 1.5 x 10^9/L, aspartate aminotransferase or alanine aminotransferase = 55% and a Fridericia-corrected QT interval (QTcF) less than 470 milliseconds; cardiac markers: cardiac troponin I (cTnI) and brain natriuretic peptide (BNP) levels were within the normal range; 9. Complete all necessary baseline laboratory and radiological examinations before neoadjuvant therapy; 10. No difficulty in swallowing; 11. Clinical data are complete.
Exclusion criteria
Exclusion criteria: 1.Male breast cancer, bilateral breast cancer, inflammatory cancer, metastatic disease (stage IV); 2.Having previously participated in other clinical trials involving anti-cancer treatment, or having undergone any anti-cancer treatment or radiotherapy for any malignant tumor (excluding carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma); 3.The coexistence of severe diseases other than non-malignant tumors will affect patients' compliance or put them in a dangerous state; 4.Having undergone major surgery within 4 weeks prior to the commencement of the study treatment or anticipating the need for major surgery during the course of the study; 5.Patients who have received breast cancer-related radiotherapy, chemotherapy, molecular targeted therapy, endocrine therapy, and have previously used TKI drugs (including pirlotinib, nilotinib, lapatinib, and tucatinib) within 4 weeks before the start of study treatment; 6.Have a history of allergic reactions or contraindications to any of the drug components in this trial; 7.Patients with chronic diarrhea, intestinal obstruction, and other diseases affecting drug administration and absorption; 8.Having uncontrolled cardiac clinical symptoms or diseases, such as: heart failure above NYHA class 2; unstable angina pectoris; myocardial infarction within 1 year; clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 9.Refractory hypertension, inability to swallow, pregnancy or breastfeeding, refusal to use contraception; 10.Dementia, intellectual abnormality, or any mental illness that impairs comprehension of the informed consent form;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor regression rate;Total Pathological Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Breast pathological complete response (bpCR);Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactXiaoan Liu
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed