An Exploratory Clinical Study of Dalpiciclib an&Amp;#39;d Letrozole Combined With Anlotinib Neoadjuvant Therapy in Stage II-III Postmenopausal HR+/HER2- Early Breast Cancer

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorLiu Shu

About this trial

This is a single-arm, open-label, exploratory clinical study

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Dalpiciclib and Letrozole Combined With Anlotinib

    Drug

    Dalpiciclib: 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

30 Participants
are divided into 1 treatment group
Group A: experimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective response rate

Time frame
24 month

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: