Breast cancer
Conditions
Interventions
Test group:Dalpiciclib (100 mg po d1-21 q4w) combined with endocrine therapy and concurrent radiotherapy
Sponsors
SHANXI PROVINCIAL CANCER HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. = 18 years old 2. Histologically confirmed HR+/HER2- early breast cancer 3. Phase IIA N1 4. Phase IIB N0, N1 5. Phase III N0, N1, N2, or N3 6. Expected to receive local radiotherapy 7. Allow chemotherapy before radiotherapy 8. The functional level of organs must meet the following requirements: (1) Bone marrow function ANC = 1.5 × 10^9/L (growth factor not used within 14 days); PLT = 100 × 10^9/L (no corrective treatment used within 7 days); Hb = 100 g/L (no corrective treatment used within 7 days); (2) Liver and kidney function TBIL = 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); (3) 12 lead electrocardiogram QT interval = 480 ms; 9. Able to accept all puncture biopsies required by the protocol; 910. Voluntarily participate in this study, sign informed consent, have good compliance, and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Recurrent or metastatic breast cancer breast cancer 2. Immunohistochemical HER2 positivity (IHC 3 or IHC 2 ISH amplification) 3. Any evidence of severe or uncontrollable systemic diseases, including uncontrolled hypertension, active hemorrhagic diseases, active infections, including hepatitis B, hepatitis C, and human immunodeficiency virus, or severe damage to bone marrow reserves or organ function, including liver and kidney damage. 4. The history of any malignancy other than breast cancer within 5 years before enrollment, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma. 5. History of severe pneumonia such as interstitial pneumonia. 6. At the beginning of the study treatment, the patient had not yet resolved any CTCAE = grade 3 toxicity caused by previous treatment. 7. Have ever suffered from any heart disease, including: (1) arrhythmia that requires medication treatment or has clinical significance; (2) Myocardial infarction; (3) Heart failure; (4) Any other heart disease determined by the researcher as unsuitable for participation in this trial; 8. Significant comorbidities, including mental illnesses that the researcher or sponsor believes will have adverse effects on the patient's participation in the study. 9. Have a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation; History of interstitial lung disease and non infectious pneumonia 10. Patients deemed unsuitable for inclusion by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of any adverse events at or above level 3; | — |
Secondary
| Measure | Time frame |
|---|---|
| Invasive disease free survival ;The proportion of radiotherapy interruptions;patient-reported outcomes; | — |
Countries
CHINA
Contacts
Public ContactWang Yu
SHANXI PROVINCIAL CANCER HOSPITAL
Outcome results
None listed