breast cancer
Conditions
Interventions
Group 1 :Dalcili in combination with standard endocrine drugs
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Local recurrence or metastasis confirmed by histological examination and newly diagnosed stage IV breast cancer patients; 2. Premenopausal or perimenopausal patients (for such patients, combined with OFS, OFS includes bilateral oophorectomy or GnRHa drugs), or postmenopausal patients; 3. Patients with bilateral breast cancer need to have metastatic lesions pathologically HR+, HER2-; 4. Pathological examination confirmed HR+, HER2- invasive breast cancer; estrogen receptor (ER) positive (> 10%), progesterone receptor (PR) positive (> 1%), HER2 negative. Follow the 2018 edition of ASCO-CAPHER2 negative interpretation guidelines. Confirmed by the pathology laboratory that the immunohistochemistry (IHC) score is 0, or 1+, or 2+ and the in situ hybridization (ISH) test is negative; 5. Women aged >= 18 years and = 12 months; 9. If endocrine therapy has been used in previous adjuvant/neoadjuvant therapy, patients with a disease-free interval of >= 12 months from the end of the last treatment of adjuvant aromatase inhibitors to tumor progression are allowed; 10. Patients with postoperative disease-free survival (DFS) >= 12 months; 11. The functional level of organs must meet the following requirements: (1) Blood routine 1) ANC >= 1.5 x 10^9/L; 2) PLT >= 90 x 10^9/L; 3) Hb >= 90 g/L; (2) Blood biochemistry 1) TBIL = 50 mL/min (Cockcroft-Gault formula); (3) Cardiac ultrasound: LVEF >= 50%; (4) 12-lead ECG: Fridericia method corrected QT interval (QTcF) < 480 ms for females; 12. Patients with known hormone receptor status; 13. Voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with central nervous system metastasis (uncontrolled/symptomatic); 2. For patients with visceral crisis, the definition of visceral crisis: abnormal function of several organs confirmed by symptoms, signs, laboratory tests, and rapid disease progression. Visceral crisis is not simply the presence of visceral metastasis, but refers to critical visceral conditions that require rapid and effective treatment to control disease progression, especially the situation where the opportunity for chemotherapy is lost after progression; 3. Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug taking and absorption; 4. Participated in other drug clinical trials within 4 weeks before enrollment; 5. Suffering from other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; 6. Receive any other anti-tumor therapy at the same time; 7. Those who are known to have a history of allergy to the drug components of this regimen; have a history of immunodeficiency, including positive HIV testing, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or organ transplantation history; 8. History of any heart disease, including: (1) Cardiac arrhythmias that require drug treatment or have clinical significance; (2) Myocardial infarction; (3) Heart failure; (4) Any other heart disease judged by the researcher to be unsuitable for participating in this trial; 9. Female patients who are pregnant or breastfeeding, female patients who are fertile and have a positive baseline pregnancy test; 10. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.); 11. There is a clear history of neurological or mental disorders in the past, including epilepsy or dementia; 12. Any other situation that the investigator thinks that the patient is not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;clinical benefit rate;duration of overall response;overall survival; | — |
Countries
China
Contacts
Public ContactPengwei Lv
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed