Early-stage and locally advanced HER2+/HR+ breast cancer
Conditions
Interventions
Control group:Docetaxel 75 mg/m^2 intravenously, carboplatin AUC=6 mg/mL intravenously, trastuzumab 8 mg/kg in cycle 1, and 6 mg/kg in each subsequent cycle
Pertuzumab is 840 mg in the first cycle, 420 mg per subsequent cycle, and the above drugs are once every 3 weeks for a total of 18 weeks
Experiment group:Nelatinib 160 mg orally once daily for 12 weeks. Albumin paclitaxel: 125 mg/m^2 once weekly, D1, D8, D15 for 12 weeks. trastuzumab: 4 mg/kg loading dose at week 1, followed by 2 mg/kg
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female naïve patients with age >=18 years old and =1.5×10^9/L; • PLT>=90×10^9/L; • Hb>=90 g/L; b) Blood biochemistry • TBIL= 50 mL/min c) Cardiac color ultrasound: LVEF>=50%; d) Lead ECG: 470 ms < women with QT interval (QTcF) corrected by Fridericia's method. 8. Patients with a negative serum pregnancy test, patients of childbearing potential must agree to use an effective non-hormonal method of contraception during treatment and for at least 6 months after the last use of trial drug. 9. Volunteer to join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients with inflammatory breast cancer; 2.Patients with metastatic breast cancer (stage IV); 3.Difficulty in swallowing, chronic diarrhea and intestinal obstruction - there are multiple factors that affect the administration and absorption of medications. 4.At the same time, in other clinical trials, they also received anti-tumor therapies, including endocrine therapy, bisphosphonate therapy or immunotherapy. 5.Within 4 weeks prior to enrollment, the patient had undergone major surgical procedures unrelated to breast cancer, or the patient had not fully recovered from such surgical procedures. 6.Previous use or current use of HER-2 targeted monoclonal antibodies or tyrosine kinase inhibitors (including trastuzumab, pertuzumab, lapatinib, neratinib and pyrotinib, etc.); 7.Having suffered from other malignant tumors within the past 5 years, excluding cured cases of cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin. 8.At the same time, receive any other anti-tumor treatments; 9.Those who have a history of allergy to the components of this treatment plan; those with a history of immunodeficiency diseases, including positive HIV test results, or suffering from other acquired or congenital immune deficiencies, or having a history of organ transplantation. 10.Has suffered from any heart disease; 11.Pregnant or lactating female patients, female patients with reproductive capacity and positive baseline pregnancy test results, or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial period; 12.According to the researchers' assessment, there are accompanying diseases that pose a significant threat to patient safety or interfere with the completion of the study (including but not limited to severe hypertension that cannot be controlled by medication, severe diabetes, active infections, etc.); 13.There is a clear history of neurological or mental disorders in the past, including epilepsy or dementia. 14.Patients who are using CYP3A4 inhibitors or inducers; 15.The researchers believe that the patient is not suitable for participating in any other aspect of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tpCR (total pathologic complete response); | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event;ORR (objective response rate);iDFS (Survival Without Invasive Disease);HRQoL (Health-Related Quality of Life);bpCR;DCR (Disease Control Rate); | — |
Countries
China
Contacts
Public ContactLuo Ting
West China Hospital of Sichuan University
Outcome results
None listed