AK105 Plus Anlotinib Hydrochloride Combined With Albumin Paclitaxel as a First-line Therapy in Patients With Advanced Triple-negative Breast Cancer

This is an interventional treatment trial for Breast Neoplasm Female Read More

Inclusion Criteria:

• Female aged 18-75 years old.
• ECOG 0 or 1 point.

• Advanced triple-negative invasive breast cancer :

  1. The pathological classification is triple negative, specifically:

     1. ER negative: IHC<1%.
     2. PR negative: IHC<1%.
     3. HER2 negative: IHC-/+ or IHC++ but FISH/CISH is negative.
  2. Tumor staging: locally advanced or recurrent/metastatic breast cancer.
• If the last chemotherapy drug in the previous adjuvant/neoadjuvant treatment stage is paclitaxel, paclitaxel liposome, paclitaxel albumin or docetaxel, it will take ≥6 months from the end of treatment to enrollment.
• At least one objectively measurable lesion according to the RECIST 1.1 .

• The main organs are functioning well, and the blood test results within 14 days before enrollment should meet the following requirements:

  1. Routine blood test:

     1. Hemoglobin (HB) ≥90 g/L.
     2. Neutrophil count (ANC) ≥1.5×109/L.
     3. Platelet count (PLT) ≥100×109/L.

  2. Biochemical test:

     1. Total bilirubin≤1.5×ULN (upper limit of normal).
     2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN.
     3. Serum creatinine (Cr) ≤1.5 ULN or creatinine clearance ≥60mL/min.
• Must not be regnant.
• Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

• Pregnant, lactating or planning to become pregnant during the study period.
• Allergic to any of the drugs in the study.
• Previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or anti-vascular targeted therapy.
• Central nervous system (CNS) metastases.

• Concomitant disease/medical history:

  1. Patients with any known or suspected autoimmune diseases.
  2. Hypertension.
  3. Peripheral neuropathy ≥ Grade 2.
  4. Persons with a history of unstable angina or arrhythmia.
  5. Active or uncontrolled serious infection .
  6. History of immunodeficiency.
  7. Active hepatitis B or C.
  8. interstitial lung disease or non-infectious pneumonia.
  9. Active tuberculosis.
  10. Urine protein is ≥++, and 24-hour urine protein quantitative is >1.0g.
  11. Suffered from other malignant tumors within 5 years before enrollment.
  12. Unreduced toxicity .
  13. Multiple factors that affect oral medications.
  14. Abnormal coagulation function.
  15. Major surgical treatment, open biopsy or traumatic injury within 4 weeks.
  16. Tumor has invaded the periphery of important blood vessels.
  17. Patients who have seizures.
  18. Bleeding constitution or medical history.
  19. Arterial/venous thrombotic events before enrollment or within 6 months.
  20. Live attenuated vaccine vaccination within 28 days before the study.
  21. Uncontrollable pleural, abdominal or pericardial effusion.
  22. Other uncontrollable systemic diseases.
• Other serious physical or mental diseases or laboratory abnormalities.
• Patients who the researcher thinks are not suitable for this research.
• Participated in clinical trials of other anti-tumor drugs within four weeks.