Status:
UNKNOWN
AK105 Plus Anlotinib Hydrochloride Combined With Albumin Paclitaxel as a First-line Therapy in Patients With Advanced Triple-negative Breast Cancer
Lead Sponsor:
Liaoning Cancer Hospital & Institute
Collaborating Sponsors:
Huludao central hospital
Anshan Tumor Hospital
Conditions:
Breast Neoplasm Female
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
This trial used a multicentre, single-arm design in which patients were treated with AK105 plus Anlotinib Hydrochloride combined with albumin paclitaxel. Patients included in this trial were advanced ...
Eligibility Criteria
Inclusion
- Female aged 18-75 years old.
- ECOG 0 or 1 point.
- Advanced triple-negative invasive breast cancer :
- The pathological classification is triple negative, specifically:
- ER negative: IHC\<1%.
- PR negative: IHC\<1%.
- HER2 negative: IHC-/+ or IHC++ but FISH/CISH is negative.
- 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:
- Routine blood test:
- Hemoglobin (HB) ≥90 g/L.
- Neutrophil count (ANC) ≥1.5×109/L.
- Platelet count (PLT) ≥100×109/L.
- Biochemical test:
- Total bilirubin≤1.5×ULN (upper limit of normal).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN.
- 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
- 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:
- Patients with any known or suspected autoimmune diseases.
- Hypertension.
- Peripheral neuropathy ≥ Grade 2.
- Persons with a history of unstable angina or arrhythmia.
- Active or uncontrolled serious infection .
- History of immunodeficiency.
- Active hepatitis B or C.
- interstitial lung disease or non-infectious pneumonia.
- Active tuberculosis.
- Urine protein is ≥++, and 24-hour urine protein quantitative is \>1.0g.
- Suffered from other malignant tumors within 5 years before enrollment.
- Unreduced toxicity .
- Multiple factors that affect oral medications.
- Abnormal coagulation function.
- Major surgical treatment, open biopsy or traumatic injury within 4 weeks.
- Tumor has invaded the periphery of important blood vessels.
- Patients who have seizures.
- Bleeding constitution or medical history.
- Arterial/venous thrombotic events before enrollment or within 6 months.
- Live attenuated vaccine vaccination within 28 days before the study.
- Uncontrollable pleural, abdominal or pericardial effusion.
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05244993
Start Date
July 1 2022
End Date
March 1 2024
Last Update
July 12 2022
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