Breast Cancer Metastatic Clinical Trial
Official title:
Apatinib in Combination With CDK4/6 Inhibitor and Endocrine Therapy as the First-line Therapy for HR+/ HER2-Advanced Breast Cancer
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Status | Recruiting |
Enrollment | 145 |
Est. completion date | June 1, 2027 |
Est. primary completion date | November 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Females =18 years and = 75 years old; - Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER> 10% tumor cell positive is defined as ER positive, PR> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative); - Subtype of similarity network fusion-4 (SNF-4) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital • Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer; - Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions; - Has adequate bone marrow function: absolute neutrophil count > 1.5x10ˆ9 /L; platelet count > 75x10ˆ9 /L, hemoglobin > 9g/dL; - Patients had received no previous chemotherapy or targeted therapy for metastatic disease - Page 3 of 4 [DRAFT] - - Has adequate liver function and kidney function: serum creatinine - ECOG score = 2 and life expectancy = 3 months; - Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up Exclusion Criteria: - Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease - Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms); - Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months); - is pregnant or breast feeding; - Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ). |
Country | Name | City | State |
---|---|---|---|
China | Breast cancer institute of Fudan University Cancer Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University | Affiliated Hospital of Nantong University, Chongqing University Cancer Hospital, First Affiliated Hospital Xi'an Jiaotong University, First Hospital of China Medical University, Fujian Medical University Union Hospital, Liaoning Tumor Hospital & Institute, Ningbo Medical Center Lihuili Hospital, Northern Jiangsu People's Hospital, Peking University Cancer Hospital & Institute, Shanghai 6th People's Hospital, Shanghai First Maternity and Infant Hospital, Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PFS | time to progressive disease (according to RECIST1.1) | Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years) | |
Secondary | ORR | The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1) | Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years) | |
Secondary | CBR | The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants. | Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years) | |
Secondary | OS | time to death due to any cause | Randomization to death from any cause, through the end of study (approximately 5 years) |
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