Breast cancer
Conditions
Interventions
experimental group:Dalpiciclib and letrozole combined with trastuzumab / patuzumab
Sponsors
Chongqing Key Laboratory for Intelligent Oncology in Breast Cancer (iCQBC),Chongqing University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients who agree and sign the written informed consent; 2.Postmenopausal or premenopausal / perimenopausal female patients aged >= 18 years and = 10% (reviewed and confirmed by the researcher of the test center); HER2 positivity is defined as an immunohistochemical (IHC) score of 3+ or an in situ hybridization (ISH) result of HER2 gene amplification. 8.Plan to accept the final surgical resection of breast cancer, namely breast conserving surgery or mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND); 9.Plan to receive neoadjuvant chemotherapy; 10.According to recist1.1, patients with at least one measurable lesion; The maximum diameter of the primary tumor measured by the standard evaluation method (MRI) in the research center is > 2 cm; 11.Patients with left ventricular ejection fraction (LVEF) >= 55% within 4 weeks before randomization; 12.Patients with suitable organs and hematopoietic function; The laboratory examination met the following criteria: neutrophil absolute count (neut) >= 1.5 x 10^9/l; leukocyte absolute count (WBC) >= 3.0 x 10^9/l; platelet >= 90 x 10^9 / L; hemoglobin >= 90g / L; serum creatinine <= 1.5 times the upper limit of normal creatinine (ULN); AST and alt <= 3.0 times ULN; serum total bilirubin (TBIL) <= 1.5 times ULN; international normalized ratio (INR) <= 1.5 times ULN, or activated partial thromboplastin time (APTT) <= 1.5 times ULN (except for subjects receiving anticoagulant therapy). 13.For female patients who are not menopausal or have not undergone surgical sterilization: during the treatment period and at least 7 months after the last administration of the drug in the study treatment, they agree to abstinence or use effective contraceptive methods. Women of childbearing age who have undergone surgical sterilization (including hysterectomy, bilateral oophorectomy or hysterectomy) or have Menopause (defined as having no menstruation for more than 12 months without medical reasons) are considered to have no possibility of pregnancy.
Exclusion criteria
Exclusion criteria: 1.Pregnant and lactating women with positive baseline pregnancy test; Women of childbearing age who do not agree to abstinence or effective contraception during the study period or within 7 months of the last administration; 2.Patients with any definite history of drug allergy, especially those with severe allergic reaction to any component of the test drug (nci-ctcae 5.0 grade greater than grade 3); 3.Patients with bilateral breast cancer and inflammatory breast cancer; 4.Patients with stage IV (metastatic) breast cancer; 5.Patients with history of congestive heart failure, unstable angina pectoris, arrhythmia or myocardial infarction; 6.Patients with other invasive tumors (including the second primary breast cancer) may affect the outcome evaluation and protocol compliance; however, patients who are cured and have disease-free survival for at least 5 years can be included; 7.Patients who have received chemotherapy, endocrine therapy and other anti-tumor treatment, or breast cancer patients who have received breast surgery (except for the diagnosis and biopsy of primary breast cancer); 8.Patients with known uncontrolled active bacterial, viral, fungal, mycobacterial, parasitic or other infections (excluding fungal infection of nail bed skin) or any major systemic infection events requiring intravenous antibiotic treatment or hospitalization (except tumor fever) within 4 weeks before enrollment; 9.Patients with human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >= 1000 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of analytical method), or co infection of hepatitis B and hepatitis C; 10.Patients who are unable to swallow, have intestinal obstruction or have other factors that affect the taking and absorption of drugs; 11.Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 12.Patients with known history of psychotropic drug abuse or drug abuse; 13.Patients with other serious physical or mental disorders or laboratory abnormalities may increase the risk of participating in the study, or interfere with the results of the study, and patients who are considered unsuitable by the researchers to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the changes of pathological ki-67 proliferation markers; | — |
Secondary
| Measure | Time frame |
|---|---|
| total pathologic complete response, tpCR;breast pathologic complete response, bpCR;objective response rate, ORR;safety;Changes of apoptotic bodies; | — |
Countries
China
Contacts
Public ContactZeng Xiaohua
Chongqing University Cancer Hospital
Outcome results
None listed