Status:
NOT_YET_RECRUITING
Pyrotinib Maleate Tablets in Combination With Dalpiciclib Isethionate Tablets and Standard Endocrine Therapy
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
Locally Advanced Breast Cancer (LABC)
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study is a prospective, exploratory clinical study design, and plans to enroll 33 patients with HR+HER2 low expression breast cancer who received pyrotinib combined with darcili and standard endo...
Eligibility Criteria
Inclusion
- Female patients aged ≥18 years and ≤75 years old, who have just been treated for breast cancer;
- Pathological examination confirmed that HR was positive (ER≥10%) and HER2 was low (immunohistochemical staining ICH++ and FISH negative);
- Patients with invasive breast cancer confirmed by pathological examination (T≥3 or N≥1) who are eligible for neoadjuvant therapy;
- ECOG score 0\~1 points;
- Planned to undergo definitive surgical resection of breast cancer, i.e., breast-conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy, or axillary lymph node dissection (ALND);
- Normal function of major organs, i.e. meeting the following criteria:
- (1) Blood routine examination standards must meet: ANC ≥1.5×109/L; PLT ≥90×109/L； Hb ≥90g/L； (2) Biochemical examination must meet the following criteria: TBIL ≤upper limit of normal (ULN); ALT and AST ≤ 1.5 times the upper limit of normal (ULN), alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN), BUN and Cr ≤ 1.5× ULN and creatinine clearance ≥ 50 mL/min (CockcroftGault formula); (3) Cardiac color ultrasound and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) 18-lead ECG corrected by Fridericia's QT interval (QTcF) in women\< 470 ms; 7. For female patients who are not menopausal or surgically sterilized: agree to abstain from sexual activity or use an effective contraceptive method during the treatment period and for at least 7 months after the last dose of study treatment; 8. Volunteer to join this study and sign the informed consent form.
Exclusion
- Those who have a known history of allergy to the drug components of this regimen;
- Previous anti-tumor therapy or radiotherapy for any malignant tumor (except for cured cervical carcinoma in situ and basal cell carcinoma);
- Underwent major surgical procedures unrelated to breast cancer within 4 weeks, or patients have not fully recovered from such surgical procedures;
- Patients with stage IV (metastatic) breast cancer;
- Inability to swallow, intestinal obstruction, or other factors affecting drug intake and absorption;
- Severe heart disease or discomfort that cannot be treated;
- Suffering from mental illness or psychotropic substance abuse and unable to cooperate;
- Pregnant or lactating female patients;
- Patients with severe liver and kidney function diseases and hematological diseases;
- Those who are not suitable for enrollment in the investigator's opinion: such as a history of drug abuse, blood products, anticoagulant drugs and immunological drugs in the past year; Those with poor compliance and refusal to cooperate with treatment; Doctors with severe hypertension and diabetes are not suitable for the study.
Key Trial Info
Start Date :
September 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT07189884
Start Date
September 23 2025
End Date
December 31 2028
Last Update
September 24 2025
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