Breast Cancer, Metastatic Cancer
Conditions
Keywords
first-line therapy
Brief summary
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Detailed description
Patients with SNF2 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. Five treatment arms were set up based on the whether they have exposed to CDK4/6 inhibitors before. The main purpose is to evaluate immune therapy in SNF2 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.
Interventions
Sponsors
Peking University Cancer Hospital & Institute
First Hospital of China Medical University
Sun Yat-sen University
First Affiliated Hospital Xi'an Jiaotong University
Liaoning Cancer Hospital & Institute
Chongqing University Cancer Hospital
Northern Jiangsu People's Hospital
Fujian Medical University Union Hospital
Ningbo Medical Center Lihuili Hospital
Shanghai First Maternity and Infant Hospital
Shanghai 6th People's Hospital
Affiliated Hospital of Nantong University
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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-2 (SNF-2) 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 * 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). * History of autoimmune disease * Positive test for human immunodeficiency virus * Active hepatitis B or hepatitis C * Uncontrolled pleural effusion and ascites * Thyroid dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 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) | time to progressive disease (according to RECIST1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 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) | The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1) |
| CBR | 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) | the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the |
| OS | Randomization to death from any cause, through the end of study (approximately 5 years) | time to death due to any cause |
Countries
China
Contacts
Primary ContactZhi-Ming Shao
Backup ContactZhong-Hua Wang
Outcome results
None listed