HR+ and Her-2+ breast cancer
Conditions
Interventions
Experimental group:Cumoxiclib combined with letrozole and trepa double target neoadjuvant therapy
Sponsors
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with the initial diagnosis of tumor stage II-III that conforms to the 8th edition of the AJCC standard; 2. Premenopausal or perimenopausal patients (if they are such patients, they need to be combined with OFS, which includes bilateral oophorectomy or GnRHa drugs), or postmenopausal patients; 3. All patients have been confirmed by pathological histology as HR+/HER2 receptor positive. Estrogen receptor (ER) positive (>10%), progesterone receptor (PR) positive (>1%), and HER2 receptor positive. Follow the 2018 ASCO-CAP HER2 positive interpretation guideline standards. The immunohistochemistry (IHC) score is confirmed to be 3+ by the pathology laboratory, or 2+ and the in situ hybridization (ISH) test is positive (ISH amplification rate >= 2.0); 4. Age 18-75 years (including 18 and 75), female; 5. ECOG score 0-1; 6. Expected survival time >= 12 weeks; 7. According to the RECIST 1.1 standard, there must be at least one measurable lesion; 8. The functional level of organs must meet the following requirements: (a) Blood routine: ANC >= 1.5×10^9/L; PLT >= 90×10^9/L; Hb >= 90g/L; (b) Blood biochemistry: TBIL = 50 mL/min; (c) Cardiac echocardiography: Left ventricular ejection fraction >= 50%; 9. The subjects voluntarily join this study, sign the informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Have previously received any form of anti-tumor treatment (such as chemotherapy, radiotherapy, molecular targeted therapy, and endocrine therapy, etc.); 2.Also receive treatment with other anti-tumor drugs; 3.Stage IV breast cancer; 4.Breast cancer that has not been confirmed by pathological tissue examination; 5.Having had any other malignant tumors within the past 5 years, except for cured cases of cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin; 6.Those with severe dysfunction of important organs such as the heart, liver and kidneysThose with severe dysfunction of important organs such as the heart, liver and kidneys; 7.Difficulty in swallowing, chronic diarrhea and intestinal obstruction, there are multiple factors that affect the administration and absorption of medications; 8.Having participated in other drug clinical trials within the previous 4 weeks before enrollment; 9.Have a history of immunodeficiency, including positive HIV test result, HCV infection, active hepatitis B, or having other acquired or congenital immune deficiency diseases, or having a history of organ transplantation; 10.Those who have a history of allergic reactions to the components of this treatment plan; 11.Has suffered from any heart diseases, including: those requiring medication or with clinically significant arrhythmia; myocardial infarction; heart failure; any other heart diseases judged by the researchers to be unsuitable for participation in this trial, etc; 12.Pregnant or lactating female patients, female patients with reproductive capacity and positive results from baseline pregnancy tests; 13.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.); 14.There is a clear history of neurological or mental disorders in the past, including epilepsy or dementia. 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 pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Breast pathological complete response;Safety;Objective Response Rate;Exploring biomarkers related to the efficacy of neoadjuvant therapy;EFS,Event-free survival; | — |
Countries
China
Contacts
Public ContactXiaoan Liu
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)
Outcome results
None listed