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New treatment option for Triple-negative Breast Cancer
Official title Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic TNBC
ClinicalTrials.gov ID: NCT05192798
What this study is testing
What is Albumin-Bound Paclitaxel?
Albumin-Bound Paclitaxel is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for triple-negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80, women only
You may be able to join if
- Female patients aged ≥18 years and ≤80 years;
- Patients with recurrent or metastatic triple negative breast cancer confirmed by histopathology and imaging;
- Presence of at least one measurable lesion according to RECIST 1.1;
- Expected survival ≥3 months;
- Eastern Cooperative Oncology Group performance status (ECOG PS) : 0-2;
You likely can't join if
- Patients who are pregnant or breast-feeding;
- Patients with multiple factors affecting oral medication (such as swallow inability, chronic diarrhea and intestinal obstruction);
- Known hypersensitivity reaction to any of the components of the treatment;
- Peripheral neuropathy ≥ grade 2, whatever the cause;
- Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically...
- Patients with urinary protein ≥++ indicated by routine urine examination, and the 24-hour urine protein level was confirmed to be \> 1.0g;
See the full eligibility criteria
- Female patients aged ≥18 years and ≤80 years;
- Patients with recurrent or metastatic triple negative breast cancer confirmed by histopathology and imaging;
- Presence of at least one measurable lesion according to RECIST 1.1;
- Expected survival ≥3 months;
- Eastern Cooperative Oncology Group performance status (ECOG PS) : 0-2;
- Patients who have not previously received antitumor systemic therapy for the stage of relapse or metastasis;
- For people 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...
- 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.
- people voluntarily agree to participate in the study and sign informed consent, with good compliance and being accessible for treatment and follow-up.
- Patients who are pregnant or breast-feeding;
- Patients with multiple factors affecting oral medication (such as swallow inability, chronic diarrhea and intestinal obstruction);
- Known hypersensitivity reaction to any of the components of the treatment;
- Peripheral neuropathy ≥ grade 2, whatever the cause;
- 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...
- Patients with urinary protein ≥++ indicated by routine urine examination, and the 24-hour urine protein level was confirmed to be \> 1.0g;
- 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...
- 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...
- 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...
- Uncontrolled effusion management (pleural effusion, pericardial effusion, or ascites) which requires frequent drainage procedures;
- 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;
- Participants in clinical trials of other antitumor drugs within 4 weeks prior to randomization;
- Other circumstances in which participation in the study would be inappropriate as determined by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.