Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic TNBC

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a prospective, randomized, open-label clinical study. 128 patients with relapsed or metastatic triple-negative breast cancer (TNBC) who had not been systematically treated are going to be enrolled and randomly assigned to 3 groups. Group A: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks). Group B: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks)+ apatinib mesylate tablet (500 mg, orally, once daily, every 3 weeks). Group C: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks) + bevacizumab (7.5mg/kg, intravenous infusion, once every 3 weeks). The dosages of therapeutic drugs are allowed to be adjusted appropriately according to the toxic reaction of the patients. Patients in three groups continued to take medication until disease progression/death/toxicity was intolerable/the patient or investigator decided to discontinue the medication.

The primary endpoint is progression-free survival (PFS). Secondary endpoints are objective response rate (ORR), CBR (CR+PR+SD (> 6 months)), overall survival (OS), adverse events (AE), and potential predictive biomarker parameters related to treatment response (VEGF-A expression level) in peripheral blood.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Bengbu Medical College
• Treatments: Albumin-Bound Paclitaxel; Apatinib; Bevacizumab; Paclitaxel

Criteria

Inclusion Criteria:

1. Female patients aged ≥18 years and ≤80 years;

2. Patients with recurrent or metastatic triple negative breast cancer confirmed by histopathology and imaging;

3. Presence of at least one measurable lesion according to RECIST 1.1;

4. Expected survival ≥3 months;

5. ECOG 0-2;

6. Patients who have not previously received antitumor systemic therapy for the stage of relapse or metastasis;

7. For subjects who have previously undergone adjuvant/neoadjuvant therapy, the time from the end of the last chemotherapy (including taxanes) to randomization should be ≥12 months; The time from the end of radical radiotherapy to randomization should be ≥6 months.

8. Major organs show good function, and the relevant examination indexes within 7 days prior to randomization meet the following requirements:

• Absolute neutrophil count ≥ 1.5 x 10^9 / L;

• Platelet count ≥ 100 x 10^9 / L;

• Hemoglobin ≥ 90 g/L;

• ALT and AST≤2.5 × upper limit of normal (ULN); ALT and AST≤5 × ULN if liver metastasis is present;

• Creatinine clearance rate(Ccr) ≥60 mL/min according to the Cockcroft-Gault formula;

• PT and APTT ≤1.5 × ULN, and international normalized ratio (INR)≤1.5 × ULN.

9. Subjects voluntarily agree to participate in the study and sign informed consent, with good compliance and being accessible for treatment and follow-up.

Exclusion Criteria:

1. Patients who are pregnant or breast-feeding;

2. Patients with multiple factors affecting oral medication (such as swallow inability, chronic diarrhea and intestinal obstruction);

3. Known hypersensitivity reaction to any of the components of the treatment;

4. Peripheral neuropathy ≥ grade 2, whatever the cause;

5. Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate <50 at rest) or QTcF ≥470 msec.

6. Patients with urinary protein ≥++ indicated by routine urine examination, and the 24-hour urine protein level was confirmed to be > 1.0g;

7. Patients with imaging showing that the tumor has invaded important blood vessels or the investigator judges that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study;

8. Patients who have experienced arteriovenous or venous thrombosis events within 6 months prior to randomization, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism;

9. Any bleeding or bleeding event ≥grade 3 within 4 weeks prior to the first dose of therapy; Or the presence of unhealed wounds, fractures, gastrointestinal diseases such as gastric and duodenal active ulcers, ulcerative colitis, or active bleeding of unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator;

10. Uncontrolled effusion management (pleural effusion, pericardial effusion, or ascites) which requires frequent drainage procedures;

11. Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix;

12. Participants in clinical trials of other antitumor drugs within 4 weeks prior to randomization;

13. Other circumstances in which participation in the study would be inappropriate as determined by the investigator.