Breast cancer
Conditions
Interventions
Experimental group:Dalpiciclib Combined Standard Endocrinology
Sponsors
Anyang Tumor Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed HR+, HER2- locally advanced metastatic and invasive breast cancer should follow the interpretation criteria of 2018 ASCO/CAP BREAST cancer HER2- testing Guidelines and 2010 ASCO/CAP BREAST cancer ER/PR testing Guidelines. HER2 positive was defined as HER3+ or 2+ immunohistochemistry (IHC) score confirmed by pathology laboratory and positive by in situ hybridization (ISH) test. ER positive was defined as the percentage of ER positive cells detected by immunohistochemistry >= 10%; 2. Premenopausal perimenopausal breast cancer (for such patients, combined WITH OFS, which includes bilateral ovariectomy or GnRHa drugs) or postmenopausal advanced or metastatic breast cancer; 3. Bilateral breast cancer patients need pathological HR+ for metastatic lesions; 4. Women aged 18-70 years; 5. ECOG score 0 ~ 2; 6. The expected survival time is not less than 12 weeks; 7. At least one measurable lesion is present according to RECIST 1.1; 8. Patients with prior adjuvant/neoadjuvant trastuzumab, pertuzumab, and chemotherapy and a disease-free interval of >= 12 months between the end of the last adjuvant/neoadjuvant trastuzumab and pertuzumab treatment and tumor progression are permitted; 9. Prior adjuvant/neoadjuvant is allowed if endocrine therapy has been used; 10. Patients with postoperative disease-free survival (DFS) >= 12 months; 11. The functional level of the organ must meet the following requirements: (1) Blood routine: ANC >= 1.5 x 10^9 / L; PLT >= 90 x 10^9 / L; Hb >= 90 g/L; (2) Blood biochemistry: TBIL = 50 mL/min (Cockcroft- Gault formula); (3) Color doppler echocardiography: LVEF >= 50%; (4) 12-lead ECG: Fridericia method corrected QT Interval (QTcF) in women < 480 ms; 12. Patients with known hormone receptor status; 13. Voluntarily participated in the study, signed informed consent, had good compliance and was willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with central nervous system metastasis (uncontrolled/symptomatic); 2. Patients with visceral crisis. Visceral crisis is defined as several organ dysfunction 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 the progression of the disease, especially the loss of chemotherapy opportunities after the progression. 3. Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug taking and absorption; 4. Patients have received radiotherapy, endocrine therapy, chemotherapy or surgical treatment (excluding local puncture or biopsy) in the relapse/metastasis stage; 5. Received radiotherapy, chemotherapy and surgical treatment (excluding local puncture or biopsy) within 4 weeks before enrollment; 6. Those who had received endocrine therapy within 2 weeks before enrollment; 7. Participated in clinical trials of other drugs within 4 weeks before enrollment; 8. Other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin; 9. Receiving any other anti-tumor therapy; 10. Known history of allergy to the drug components of this regimen; Have a history of immunodeficiency, including HIV positive, HCV, active hepatitis B or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 11. History of any heart disease, including: (1) Medically required or clinically significant arrhythmia; (2) Myocardial infarction; (3) Heart failure; (4) Any other heart disease deemed unsuitable for the study by the investigator; 12. Pregnant women, lactation women, fertile women with positive baseline pregnancy test; 13. Concomitant diseases (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.) that seriously endanger patient safety or affect the completion of the study, as determined by the investigator; 14. Have a clear past history of neurological or psychiatric disorders, including epilepsy or dementia; 15. The investigator did not consider the patient suitable for any other conditions in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Clinical Benefit Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Countries
China
Contacts
Public ContactJing Sun
Anyang Tumor Hospital
Outcome results
None listed