HR positive/HER2 negative early breast cancer
Conditions
Interventions
Dalcilib combined with aromatase inhibitors and capecitabine neoadjuvant therapy:Dalcilib combined with aromatase inhibitors and capecitabine neoadjuvant therapy
Sponsors
Fujian Medical University Affiliated Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: For postmenopausal or premenopausal/perimenopausal female patients aged = 18 years and = 75 years, one of the following conditions must be met: Previously underwent bilateral oophorectomy, or aged = 60 years o 2: All patients are estrogen receptor (ER) positive (>10%), regardless of PR expression levels, HER2 receptor negative invasive breast cancer. Follow the 2018 ASCO-CAP HER2 Negative Interpretation Guidelines standard. Confirmed by the pathology laboratory, the immunohistochemical (IHC) score is 0+, Or 2+and negative in situ hybridization (ISH) detection (HER-2/CEP17 ratio<2.0) 3: Newly treated patients in stages II-III who meet the AJCC 8th edition criteria for tumor staging 4: Inability to tolerate intravenous chemotherapy, suitable for special populations with oral chemotherapy combined with endocrine neoadjuvant therapy 5. It is known that there are no severe hypersensitivity reactions to compounds or endocrine therapies similar to the investigational drug and its excipients. 6. The Eastern Cancer Collaborative Group (ECOG) physical condition score is ECOG 0-1 5: It is known that there is no severe hypersensitivity reaction to compounds or endocrine therapies similar to the investigational drug and its excipients; 6: (ECOG) physical condition score is ECOG 0-1; 7: Women of childbearing age must undergo a serum pregnancy test within 28 days before enrollment, and the result is negative. Male/female patients are willing to use a medically recognized and efficient contraceptive method during the study period and within 1 year after the last administration of the study medication; 8: Non pregnant or non lactating female patients; 9: Not simultaneously participating in other ongoing research; 10: The functional level of organs must meet the following requirements: bone marrow function ANC = 1.5 × 109/L (growth factor not used within 14 days); PLT = 100 × 109/L (no corrective treatment used within 7 days); Hb = 100 g/L (no corrective treatment used within 7 days); Liver and kidney function TBIL = 1.5 × ULN; ALT and AST = 3 × ULN (ALT and AST = 5 × ULN in patients with liver metastasis); BUN and Cr = 1.5 × ULN with creatinine clearance rate = 50 mL/min (Cockcroft Gault formula); QT interval of lead electrocardiogram = 480 ms; 11: Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1: Previously received any form of anti-tumor therapy (chemotherapy, radiation therapy, molecular targeted therapy, endocrine therapy, etc.) 2: Simultaneously receiving any anti-tumor treatment other than those specified in other protocols 3: Bilateral breast cancer, inflammatory breast cancer or occult breast cancer 4: Stage IV breast cancer 5: Other malignant tumors have appeared within the past 5 years 6: Severe dysfunction of important organs such as heart, liver, and kidney 7: Difficulty in swallowing, chronic diarrhea, and intestinal obstruction, with multiple factors affecting medication administration and absorption 8: Individuals with a known history of allergies to the drug components of this protocol Having a history of immunodeficiency, including HIV testing positive, HCV Active hepatitis B or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation 9: 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 serious hypertension, serious diabetes, active infection, etc. that cannot be controlled by drugs) 10: Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia. The researchers believe that the patient is not suitable to participate in any other circumstances of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ki67;pCR; | — |
Countries
China
Contacts
Public ContactHan Zhonghua
Fujian Medical University Affiliated Union Hospital
Outcome results
None listed