Breast Cancer
Conditions
Interventions
Patients Sensitive to Hormonal Therapy combined with HER2-targeted therapy:Trastuzumab, Pyrotinib and AI
Sponsors
Breast Surgery of the First Hospital of China Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female breast cancer patients in postmenopausal status who received first treatment; 2. ECOG Performance Status 0-1; 3. Patient with the following tumour clinical characteristics: -- histological confirmation of invasive breast cancer; -- cTNM staging II-IIIA; N0 or N1; 4. Pathologically confirmed HER2-positive breast cancer, which is defined as the immunohistochemistry score of > 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification; 5. Estrogen receptor (ER) immunohistochemistry score > =10% and progesterone receptor (PR) status is known; 6. Ki67 status is known; 7. The functional level of the main organs must meet the following requirements (no blood transfusion and no use of leukocytes- and platelets-raising drugs in 2 weeks before screening): absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelet (PLT) count >= 90 x 10^9/L, hemoglobin (Hb) >= 90 g/L, total bilirubin (TBIL) 55%, corrected QT interval by Fredericia (QTcF) < 470 ms; 8. A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.
Exclusion criteria
Exclusion criteria: 1. Inflammatory breast cancer; 2. Patients who had received antineoplastic therapy or radiotherapy for any malignant tumors, but excluding cured cervical cancer in situ, basal cell carcinoma or squamous cell carcinoma; 3. Patients who are receiving anti-cancer therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy; 4. Those who had undergone major breast cancer-free operations within 4 weeks, or who had not yet fully recovered from such surgeries; 5. Severe cardiac diseases or discomforts; 6. Inability to swallow, intestinal obstruction or other factors affecting drug use and absorption; 7. Anyone with known history of allergy to the components of study drugs; history of immunodeficiency, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation; 8. Patients with severe concomitant diseases or other complications that interfere with planned treatment or in any other case considered unsuitable by the researchers to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathologic complete response (tpCR) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Event-free survival;Disease-free survival;Distant disease free survival; | — |
Countries
China
Contacts
Public ContactBo.Chen
The First Hospital of China Medical University
Outcome results
None listed