About this trial
This is a single-arm, open-label, exploratory clinical study
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Bone marrow function ANC ≥ 1.5×109/L (no granulocyte stimulating factor was used within 14 days); PLT ≥ 100×109/L (no corrective therapy used within 7 days); Hb ≥ 100 g/L (no corrective therapy 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 and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
12-lead electrocardiogram QT interval ≤480 ms; 8. Able to accept 2 puncture biopsies required by the protocol (puncture at the first diagnosis and puncture on the 15th day of medication) 9. Voluntarily participate in this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Disqualifiers
Previously received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
At the same time receive any anti-tumor treatment other than that prescribed in other protocols;
Bilateral breast cancer, inflammatory breast cancer or ocessive breast cancer;
Stage IV breast cancer;
Trial design
Single group
Treatments tested in this trial
Dalpiciclib and Letrozole Combined With Anlotinib
DrugDalpiciclib: 150mg orally, once daily, d1-d21, every 28 days as a cycle (3 weeks / 1 week off) Letrozole: 2.5mg orally once daily (continuous) Anlotinib: 12mg orally, once daily, d1-d14, every 21 days as a cycle (use 2 weeks/stop 1 week). One of the last cycles of the new auxiliary The combination of anlotinib is not included in the treatment regimen to ensure that the time interval between anlotinib withdrawal and surgery is more than 2-3 weeks.
Treatment groups
Trial outcomes
Primary outcomes
ORR
Objective response rate
Locations
Sponsors and contacts
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Liu Shu
Lead sponsor
The Affiliated Hospital Of Guizhou Medical University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: