Combining albumin-bound paclitaxel with antiangiogenic agents for treating relapsed or metastatic triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a prospective, randomized, open-label study involving 128 female patients aged 18 to 80 with relapsed or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy. Participants will be randomly assigned to one of three treatment groups: one receiving albumin-bound paclitaxel alone, another receiving it in combination with apatinib mesylate, and the third receiving it with bevacizumab. The primary goal is to evaluate progression-free survival (PFS) among the different treatment regimens, with adjustments to dosages allowed based on patient tolerance and toxicity. This study aims to explore the efficacy and safety of these combinations as first-line treatments for TNBC.

Why it matters

Who can join: the full rules

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. Eastern Cooperative Oncology Group performance status (ECOG PS) : 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;
   * Alanine aminotransferase (ALT) and aspartate transaminase (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;
   * Prothrombin time (PT) and activated partial thromboplastin time (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 heart rate-corrected QT interval via Fridericia (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.

Where it's running

• Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
  Bengbu, Anhui, China Recruiting

Study contacts

• Principal investigator: Yan Yang, M.D.,Ph.D — The First Affiliated Hospital of Bengbu Medical University
• Study coordinator: Jing Liu, M.D.
• Email: 15805692769@163.com
• Phone: +86-0552-3086178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.