Breast Cancer
Conditions
Interventions
Group 1:Dalpiciclib+endocrine therapy
Sponsors
Dongguan Donghua Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following conditions in order to be enrolled in this study: 1.Women patients aged =18 years and =75 years, either postmenopausal or pre/perimenopausal. 2.Histologically confirmed stage II-III (a) ?A-N0: Grade 2 with high risk [Ki67=20% or high-risk gene characteristics], Grade 3, N1; (b) Anatomical stage ?B: N0 or N1; (c) Anatomical stage ?: N0, N1, N2, or N3, invasive breast cancer: 1) HR-positive defined as ER-positive: Positive staining tumor cells accounting for =10% of all tumor cells (confirmed by the pathology department of the research center), regardless of PR expression status; 2) HER2-negative defined as: Immunohistochemistry (IHC) testing as 0/1+; IHC testing as 2+, ISH testing as negative (confirmed by the pathology department of the research center). 3.Subjects with prior treatment for breast cancer must fulfill the following conditions simultaneously: 1) Subjects who have undergone neoadjuvant or adjuvant chemotherapy must have received at least 4 cycles of treatment, with the chemotherapy regimen including taxanes or anthracycline drugs; 2) The interval between completion of curative surgery and enrollment does not exceed 14 months; 3) Subjects who have received adjuvant chemotherapy should have an interval of at least 21 days between the last chemotherapy administration and enrollment; 4) Subjects who have received adjuvant radiotherapy should have an interval of at least 14 days between the last radiotherapy session and enrollment; 5) The cumulative duration of non-endocrine therapy (including surgery, radiation therapy, chemotherapy) should not exceed 2 months (calculated on a 30-day basis), and treatment-related adverse events should be =grade 1; 6) The duration of adjuvant endocrine therapy should not exceed 12 months, and treatment-related adverse events should be =grade 1. 4.Underwent curative surgical resection for breast cancer or pathologically confirmed absence of infiltrating residual carcinoma and ductal carcinoma in situ (allowing residual lobular carcinoma in situ) after breast-conserving surgery. 5.Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. 6.Adequate organ and bone marrow function, as defined below: 1) Absolute neutrophil count (ANC) =1,500/mm3 (1.5×109/L) (without G-CSF treatment in the past 14 days); 2) Platelet count (PLT) =100,000/mm3 (100×109/L) (without correction therapy in the past 7 days); 3) Hemoglobin (Hb) =9g/dL (90g/L) (without correction therapy in the past 7 days); 4) Serum creatinine =1.5 times the upper limit of normal or creatinine clearance =60ml/min (without correction therapy in the past 7 days); 5) Total bilirubin (TBIL) =1.5 times the upper limit of normal (without correction therapy in the past 7 days); 6) Aspartate transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT) levels =1.5 times the upper limit of normal (without correction therapy in the past 7 days). 7.Fertile women must undergo a serum pregnancy test within 7 days before enrollment, with a negative result, and agree to use acceptable non-hormonal contraceptive measures from the start of informed consent signing until 7 months after the last dose of palbociclib or 2 months after the last dose of endocrine therapy (whichever is longer). 8.All acute toxicities from previous anti-tumor treatments should have resolved to grade 0-1 (according to NCI CTCAE version 5.0) or to the level specified in the enrollment/exclusion criteria, except for other toxicit
Exclusion criteria
Exclusion criteria: If any of the following criteria are met, the participant will not be allowed to enter this study: 1.Pathological diagnosis of HER2-positive breast cancer. 2.Local or regional recurrent disease of malignant breast tumor. 3.Clinical stage IV (metastatic) breast cancer. 4.Bilateral breast cancer, inflammatory breast cancer. 5.History of any malignant tumor other than breast cancer within 5 years prior to enrollment, excluding cured cervical carcinoma in situ, thyroid cancer, basal cell carcinoma, or squamous cell carcinoma of the skin. 6.History of severe pneumonia, such as interstitial pneumonia. 7.Previous treatment with CDK4/6 inhibitors, palbociclib, other anti-tumor biologic therapy, or tumor immunotherapy. 8.Concurrent participation in other clinical trials involving anti-tumor therapy (including endocrine therapy or immunotherapy). 9.Underwent major surgical procedure, received investigational drug or other anti-cancer treatment (excluding chemotherapy, radiation therapy, and endocrine therapy for breast cancer) within 4 weeks prior to enrollment. 10.Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBVDNA = 500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the assay), or co-infection of hepatitis B and hepatitis C. 11.Within 6 months prior to enrollment, occurrence of the following conditions: myocardial infarction, severe/unstable angina, NYHA class II or higher heart failure, persistent arrhythmia of grade = 2 (according to NCI CTCAE version 5.0), any level of atrial fibrillation, coronary/peripheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), and symptomatic pulmonary embolism. 12.Occurrence of severe infection within 4 weeks prior to enrollment (such as requiring intravenous administration of antibiotics, antifungals, or antivirals based on clinical guidelines), or unexplained fever > 38.5°C during screening period/prior to first dose. 13.Unable to swallow, intestinal obstruction, or other factors affecting drug intake and absorption. 14.Known allergy to aromatase inhibitors, tamoxifen, toremifene, LHRH agonists, palbociclib, or any excipients. 15.History of known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 16.Known history of substance abuse or drug addiction. 17.Within 1 year postpartum or currently breastfeeding. 18.Presence of other serious medical or psychiatric conditions or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results, as determined by the investigator to be unsuitable for participation in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival;Distant Disease-Free Survival;OverallSurvival;Safety;Tolerance; | — |
Primary
| Measure | Time frame |
|---|---|
| Invasive Disease-Free Survival; | — |
Countries
China
Contacts
Public ContactOuYangjie
Dongguan Donghua Hospital
Outcome results
None listed