Breast cancer
Conditions
Interventions
Single group:Dalpiciclib, pyrotinib, trastuzumab, and letrozole
Sponsors
The first affiliated hospital of SOOCHOW university
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Women aged=18 years and =75 years meeting one of the following conditions: (1) Those previously receiving ovariectomy, or aged =60 years (2) Those aged 10%) and positive human epidermal growth factor receptor 2 (HER2) according to the 2018 American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) human epidermal growth factor receptor 2 (HER2) guideline. ER and HER2 will be considered positive if the immunohistochemistry (IHC) result is positive (score 3+), or the IHC result is positive (2+) and in situ hybridization (ISH) amplification rate (=2.0); 3. Women having stage II-III breast cancer diagnosed based on AJCC cancer staging system (8th edition) who will be admitted because of breast cancer for the first time; 4. Eastern Cooperative Oncology Group Performance Status =1. 5. The functional level of organs must meet the following requirements: 1) Bone marrow function i) Absolute neutrophil count(ANC)=1.5×109/L (no use of growth factor within 14 days) ii) Platelet count(PLT)=100×109/L (no corrective treatment within 7 days) iii) Hemoglobin level(Hb)=100 g/L (no corrective treatment within 7 days) b) Liver and kidney function i) Total bilirubin(TBIL)=1.5 upper limit of normal value (ULN) ii) Alanine transaminase (ALT) and aspartate transaminase (AST) =3×ULN iii) Blood urea nitrogen (BUN) and creatinine =1.5×ULN and creatinine clearance=50mL/min(Cockcroft-Gault formula); c) Color Doppler echocardiography: Left ventricular ejection fraction =50%; d) 12-lead electrocardiography: QTc interval =480 ms 6. Women who can undergo a biopsy; 7. Volunteers to participate in the study, provision of signed informed consent, good compliance and willingness to cooperate with follow-ups.
Exclusion criteria
Exclusion criteria: 1.Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy); 2. Those who have received other anti-tumor drug treatments concurrently; 3. Those who have bilateral breast cancer, inflammatory breast cancer or occult breast cancer; 4. Those who have stage IV breast cancer; 5. Those who have breast cancer not histopathologically confirmed; 6. Those who have other malignant tumors (with the exception of healed cervical carcinoma in situ) occurring in the past 5 years; 7. Those who have severe dysfunction of the heart, liver, kidney, and other major organs; 8. There are multiple factors that affect drug administration and absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 9. Those who have participated in other clinical drug trials in the past 4 weeks; 10. Those who are known to have a history of allergy to the component of study drugs; those who have a history of immunodeficiency, including positive detection of human immunodeficiency virus, hepatitis C virus, active hepatitis B or other acquired, congenital immunodeficiency diseases, or organ transplantation; 11. Those who had suffered from any heart disease, including arrhythmia which requires drug treatment or is of clinical significance; myocardial infarction; heart failure; and any other heart disease judged by the investigator as unsuitable for this trial; 12. Pregnant and lactating women; fertile women who provide positive results of baseline pregnancy test; women of childbearing age who are unwilling to take effective contraceptive measures during the whole study period; 13. If the accompanying diseases (including, but not limited to, severe hypertension, severe diabetes, and active infection, which cannot be controlled by drugs) that would be a potential hazard to participant's health, or affect the completion of the study as per investigator's judgement; 14. A clear history of neurological or psychiatric disorders, including epilepsy or dementia. Upon the suggestion of the investigators for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathological complete response (tpCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate(ORR);Molecular Target:Ki67;Total pathological complete response (RCB system);Adverse event (AE) and serious adverse event (SAE) according to NCI CTCAE 5.0; | — |
Countries
China
Contacts
Public ContactZhaoji Guo
The first affiliated hospital of SOOCHOW university
Outcome results
None listed