Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
For patients with HER2-positive early-stage breast cancer, NCCN guidelines recommend chemotherapy plus targeted therapy as the standard adjuvant treatment for patients with tumors larger than 1 cm or lymph node-positive. The APT study enrolled patients with stage I HER2-positive breast cancer and has confirmed the efficacy and safety of intravenous chemotherapy combined with targeted therapy, but only 2.2% of the patients enrolled in microinvasion are enrolled, and there is a lack of large sample size data to provide a treatment reference for these patients. In order to further explore the optimal strategy for adjuvant therapy in this type of patient, we designed a new clinical trial to evaluate the efficacy and safety of oral capecitabine plus pyrotinib as adjuvant therapy in previous retrospective studies.
• Women aged 18-70;
• The pathology of early breast cancer after surgery is T1micN0: histologically confirmed that the longest diameter of invasive cancer does not exceed 1mm or the maximum diameter of multiple invasive lesions is less than 1mm, and the lymph node is negative (N0);
• The pathological type of immunohistochemistry needs to meet the following conditions: HER-2 (3+) or HER-2 (0-2+) but amplified by FISH detection.
• Hormone receptor negative (HR-) is defined as ER, PR expression is \<1%; Hormone receptor positivity (HR+) is defined as ER and/or PR expression ≥1%.
• For patients with both invasive lesions, if both lesions are HER-2 positive, they can be enrolled.
• ECOG score≦ 1 point;
• No obvious dysfunction of major organs;
• Blood routine: ANC ≥1.5×109/L, PLT≥100×109/L, blood Hb≥ 9 g/dl (no transfusion within 14 days);
• Liver function: total bilirubin ≤1.25×ULN; AST and ALT \<2.5×ULN;
⁃ Renal function: creatinine clearance ≥ 50 mL/min, blood creatinine ≤ 1.5 ×ULN;
⁃ Cardiac function: ECG is generally normal, QTc\< 470 ms; LVEF \> 50%;
⁃ contraception during treatment for women of childbearing age;
⁃ No history of other malignant tumors in the past 5 years;
⁃ With the consent of the person and signed the informed consent form, or signed by the patient's legal representative with the authorization of the patient.
⁃ Can be followed up and good compliance.