Breast cancer
Conditions
Interventions
Experimental group:Trastuzumab, 8 mg/kg first, followed by 6 mg/kg every 3 weeks for 6 cycles.
Pertuzumab 840 mg first, followed by 420 mg every 3 weeks for 6 cycles.
Palbociclib, 125 mg, orally, once
Sponsors
Tianjin Cancer Institute &Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Female patients aged >=18 and 1% staining) HER2-positive defined as IHC 3+, or IHC 2+ with in situ hybridization (ISH) amplification (ratio >=2.0) 5.At least one measurable lesion by CT or MRI per RECIST 1.1 criteria. 6.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7.Baseline left ventricular ejection fraction (LVEF) >=55% as measured by echocardiogram (ECHO, preferred) or multigated acquisition (MUGA) scan. 8.Adequate hematological function (no blood products, hematopoietic growth factors, or leukopoietic agents within 14 days prior to randomization): White blood cell count >=3.0×10^9/L Hemoglobin >=90 g/L Absolute neutrophil count >=1.5×10^9/L Platelet count >=100×10?/L 9.Adequate hepatic and renal function: Total bilirubin <=1.5×ULN (<=2×ULN for Gilbert's syndrome) AST <=2.5×ULN ALT <=2.5×ULN Alkaline phosphatase <=2.5×ULN Serum creatinine <=1.5×ULN 10.Adequate coagulation function: INR <=1.5 aPTT <=1.5×ULN 11.For women of childbearing potential (WOCBP): Must use medically approved contraception (IUD, oral contraceptives, or barrier methods) during treatment and for 3 months after treatment completion Negative serum or urine hCG test within 7 days prior to treatment initiation Must be non-lactating Male patients with WOCBP partners must use effective contraception during treatment and for 3 months after treatment completion 12.Willing to participate and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Bilateral breast cancer, evidence of metastatic disease (M1), or inflammatory breast cancer. 2. Prior anticancer therapy, including radiotherapy, chemotherapy, surgery (except biopsy), endocrine therapy, targeted therapy, or immune checkpoint inhibitors for any malignancy. 3. Concurrent use of strong CYP3A inhibitors or inducers. 4. Ongoing systemic antitumor therapy (except protocol-specified treatments). 5. Investigational treatment for non-malignant conditions within 4 weeks prior to enrollment. 6. History of other malignancies, except adequately treated non-melanoma skin cancer or carcinoma *in situ* of the cervix. 7. Conditions impairing drug absorption (e.g., dysphagia, chronic diarrhea, intestinal obstruction). 8. Hypersensitivity to protocol-specified drugs; immunodeficiency (e.g., HIV-positive, active HBV/HCV infection, congenital/acquired immunodeficiency); or prior organ transplantation. 9. Clinically significant cardiac disease, including: (1) Arrhythmia requiring medication; (2) Myocardial infarction; (3) Heart failure (NYHA Class II–IV); (4) Any other condition deemed unsafe by the investigator. 10. Uncontrolled comorbidities (e.g., severe hypertension, diabetes, active infections) that may compromise patient safety or study compliance. 11. Live vaccination within 4 weeks before treatment or planned during the study. 12. Pregnancy, lactation, or refusal to use contraception (if applicable). 13. Any other condition rendering the patient unsuitable for participation per investigator judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tpCR:ypT0/is N0; | — |
Countries
China
Contacts
Public ContactLu Ning
Tianjin Cancer Institute &Hospital
Outcome results
None listed