Breast Cancer
Conditions
Interventions
Experimental group1:trastuzumab +pertuzumab + aromatase inhibitor + dalpiciclib
Experimental group2:trastuzumab +pertuzumab + aromatase inhibitor
Control Group:trastuzumab +pertuzumab+taxanes
Sponsors
The Second Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Local recurrent or metastatic HR+HER2+ breast cancer diagnosed by imaging and pathology; 2.Female, age >= 18 years old; 3.The local laboratory evaluates primary or metastatic tumors as HER2 positive, which is defined as the immunohistochemical of HER2 is 3 + or the fluorescence in situ hybridization (FISH) is +; 4.The local laboratory evaluates primary or metastatic tumors as hormone receptor positive, requiring ER >= 10% and PR >= 10%; 5.Not suitable for radical resection or radiotherapy; 6.No previous anticancer treatment for local recurrent or metastatic diseases, such as systemic endocrine therapy, chemotherapy, biological therapy or targeted therapy. The use of traditional Chinese medicine for anti-cancer treatment must be stopped at least 2 weeks before random grouping; 7.With at least one measurable diseases according to the RECIST v1.1, expect the only bone metastases; 8.ECOG PS was 0-1; 9.Left ventricular ejection fraction (LVEF) >= 50%; 10.The expected survival time >= 12 weeks; 11.Adequate hematology, liver function and renal function: absolute neutrophil count (ANC) >= 1500/mL, platelet >= 100000/mL, hemoglobin >= 8g/dL, serum total bilirubin <= 1.5x normal upper limit (ULN), and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3.0*ULN (or ALT and AST <= 5*ULN if liver metastasis occurs). Serum creatinine <= 1.5*ULN. 12.Local radiotherapy for palliative treatment or osteolytic lesions at risk of fracture was stopped at least 2 weeks ago before randomization and recovered from the acute effects of previous treatment (toxicity was alleviated to baseline or at least level 1). Except for residual alopecia or peripheral neuropathy; 13.Able to swallow tablets and capsules; 14.Willing to participate in the whole research process, follow the research procedure, and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous systemic anti-tumor therapy for metastatic or local advanced breast cancer; 2. Disease progression occurred during or within 1 year after the treatment of (new) adjuvant trastuzumab or pertuzumab; 3.Primary endocrine resistance ,meaning that disease progression occurred within 2 years of adjuvant endocrine therapy; 4.The disease-free interval (from the end of neoadjuvant or adjuvant systemic non-endocrine therapy to disease recurrence) is less than 6 months; 5.Visceral crisis; 6.Central nervous system (CNS) metastasis or severe cardiovascular disease diagnosed by clinical or imaging diagnosis; 7. Bisphosphonates were used within 7 days before random grouping; 8. Participate in another clinical trial within 4 weeks before the enrollment study (or 3 months in the case of a monoclonal drug clinical trial); 9.Pregnant or lactating; 10.Serious uncontrollable infectious diseases, serious underlying diseases, mental illness; 11. Received a major surgery within 14 days before random grouping; 12. History of other cancers, except cervical carcinoma in situ, basal cell carcinoma of the skin,or squamous cell carcinoma of the skin, which have received radical treatment in the past; 13. Any history of drug hypersensitivity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Objective remission rate;Disease control rate;Clinical benefit rate;Safety;Quality of life score; | — |
Countries
China
Contacts
Public ContactLi Man
The Second Affiliated Hospital of Dalian Medical University
Outcome results
None listed