Observational Study on the Sensitivity of Neoadjuvant Immunotherapy in Early Triple-Negative Breast Cancer

Launched by SHANDONG UNIVERSITY · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a type of cancer treatment called neoadjuvant immunotherapy works for women with early-stage triple-negative breast cancer. This treatment is given before surgery to help shrink the tumor and improve the chances of a successful outcome. The study aims to understand the immune response in patients by analyzing specific immune cells in their tumors. Researchers believe that changes in these immune cells can provide important information about how well the treatment is working.

To participate in this trial, women must be between 18 and 60 years old and have been diagnosed with triple-negative breast cancer, which means their tumors do not have certain hormone receptors. They also need to have cancer that hasn’t spread to other parts of the body and must be in good overall health to tolerate the treatment. Participants will be closely monitored throughout the study, and their health will be evaluated to ensure safety. This trial is not yet recruiting participants, but it represents an exciting opportunity to better understand how immunotherapy can help in the fight against this challenging type of breast cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18-60 years old;
• • 2. Histologically confirmed triple-negative breast cancer, with immunohistochemistry showing ER \<1%, PR \<1%, HER2-negative (IHC 0 or 1+; or IHC 2+ ISH-negative);
• • 3. Imaging-confirmed non-metastatic disease;
• • 4. Clinical efficacy can be evaluated according to RECIST criteria;
• • 5. European Functional Handicap Scale (MRC) of 0-2;
• • 6. The investigator determines that the treatment is tolerable based on the patient's organ function level;
• • 7. Volunteers willing to participate in this study, sign the informed consent, have good compliance, and are willing to cooperate with follow-up.
• Exclusion Criteria:
• • 1. Immunohistochemistry showing HER2-positive (IHC 3 or IHC 2 ISH-amplified);
• • 2. Previously treated;
• • 3. Severe dysfunction of important organs such as heart, liver, and kidneys;
• • 4. Patients with diseases unsuitable for immunotherapy;
• • 5. Known allergy history to any component of the drugs in this regimen;
• • 6. History of immune deficiency, including HIV-positive, HCV, active hepatitis B, or other acquired or congenital immune deficiency diseases, or a history of organ transplantation;
• • 7. Any cardiac disease, including: ① Medically treated or clinically significant arrhythmias; ② Myocardial infarction; ③ Heart failure; ④ Any other cardiac disease judged by the investigator as unsuitable for participation in this trial;
• • 8. Pregnant or lactating women, fertile women with positive baseline pregnancy test or those unwilling to take effective contraceptive measures during the entire trial;
• • 9. According to the investigator's judgment, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension uncontrollable by drugs, severe diabetes, active infections, etc.);
• • 10. Long-term use of drugs that affect the components of peripheral blood immune cells, such as recombinant human erythropoietin, recombinant human granulocyte colony-stimulating factor, recombinant human interleukin, or Likejun tablets;
• • 11. Received immunosuppressive therapy within 2 weeks;
• • 12. Hematological precancerous diseases, such as myelodysplastic syndrome, and coagulation disorders.