SNF Platform Study of HR+/ HER2-advanced Breast Cancer

Launched by FUDAN UNIVERSITY · Oct 25, 2022

Keywords

ClinConnect Summary

The SNF Platform Study is a clinical trial designed to explore new treatment options for women with advanced breast cancer that is hormone-receptor-positive and HER2-negative. This study is specifically looking at patients who have already been treated with a type of therapy called CDK4/6 inhibitors. Researchers want to test whether targeted treatments based on the specific characteristics of a patient’s cancer can be more effective. The trial is currently recruiting participants aged 18 and older who meet certain health criteria, including having measurable cancer that hasn’t been treated with other therapies in the last few weeks.

Eligible participants can expect to undergo tests to confirm their cancer type and overall health. If they join the trial, they will receive close monitoring and follow-up care. It’s important to note that participants should not have uncontrolled health issues or recent treatments that could interfere with the study. This trial aims to find better ways to treat advanced breast cancer, and participants will play a key role in helping researchers gain valuable insights.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Female aged ≥18 years;
• • 2. HR+/HER2- invasive breast cancer confirmed by histology (specific definition: ER \>10% positive tumor cells by immunohistochemistry is defined as ER positive, PR \>10% positive tumor cells is defined as PR positive, ER and/or PR positive is defined as HR positive; HER2 0-1+ or HER2 + but negative by FISH without amplification was defined as HER2 negative);
• • 3. Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;
• • 4. HR+/HER2- advanced breast cancer patients who had previously received CDK4/6 inhibitor therapy;
• • 5. At least one measurable lesion according to RECIST 1.1 (conventional CT scan ≥20 mm, spiral CT scan ≥10 mm, measurable lesion has not received radiotherapy);
• 6. The functions of the main organs are basically normal and meet the following conditions:
• • I. Blood routine examination criteria shall meet: HB ≥90 g/L (no blood transfusion within 14 days); The ANC acuity 1.5 x 109 / L; PLT acuity 75 x 109 / L; Ii. Biochemical tests should meet the following criteria: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3×ULN; If liver metastases were present, ALT and AST≤ 5×ULN; Serum Cr ≤1×ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula);
• • 7. They have not received radiotherapy, molecular targeted therapy, or surgery within 3 weeks before the start of the study, and have recovered from the acute toxicity of previous treatment (if surgery was performed, the wound has healed completely); No peripheral neuropathy or grade I peripheral neurotoxicity;
• • 8. ECOG score ≤2, and life expectancy ≥3 months;
• • 9. Fertile female subjects were required to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the study drug;
• • 10. Subjects volunteered to join the study, signed informed consent, had good compliance, and cooperated with follow-up.
• Exclusion Criteria:
• • 1. Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);
• • 2. Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);
• • 3. A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;
• • 4. Persistent grade 1 or higher adverse reactions caused by previous treatments. The exception to this is hair loss or something the researchers don't think should be ruled out. Such cases should be clearly documented in the investigator's notes;
• • 5. Underwent major surgery (except minor outpatient procedures, such as placement of vascular access) within 3 weeks of the first course of trial treatment;
• • 6. Pregnant or lactating patients; Malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years.