Actively Recruiting
A Prospective, Randomized, Open Label Clinical Study Evaluating Efficacy and Safety of Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic Triple Negative Breast Cancer
Led by The First Affiliated Hospital of Bengbu Medical University · Updated on 2025-02-27
128
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for women with relapsed or metastatic triple-negative breast cancer (TNBC), a type of breast cancer that does not respond to hormone or HER-2 targeted therapies. This prospective, randomized, open-label clinical trial involves 128 patients who have not previously received systemic treatment for this stage of their cancer. The study aims to compare the effects of albumin-bound paclitaxel alone and in combination with antiangiogenic agents on disease progression and survival. Participants are randomly assigned to one of three groups: Group A receives albumin-bound paclitaxel intravenously every three weeks; Group B receives the same chemotherapy plus daily oral apatinib mesylate tablets; Group C receives albumin-bound paclitaxel combined with bevacizumab intravenously every three weeks. Dosages may be adjusted based on patient tolerance. Treatment continues until disease progression, intolerable toxicity, death, or patient or investigator decision to stop. During the study, patients will be closely monitored through imaging and laboratory tests to measure tumor response and side effects. Researchers will track progression-free survival as the primary outcome, along with response rates, overall survival, adverse events, and blood biomarkers related to treatment response. The study spans up to two years, with ongoing assessments to evaluate safety and treatment effectiveness.
CONDITIONS
Brief Title
Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years and older up to 80 years
- Diagnosed with recurrent or metastatic triple-negative breast cancer confirmed by histopathology and imaging
- At least one measurable lesion according to RECIST 1.1
- Expected survival of 3 months or more
- Eastern Cooperative Oncology Group performance status (ECOG PS) between 0 and 2
- No prior systemic antitumor therapy for relapse or metastatic stage
- At least 12 months since last chemotherapy if previously treated with adjuvant/neoadjuvant therapy
- At least 6 months since last radical radiotherapy if previously treated
- Adequate organ function with specified blood counts and liver, kidney, and coagulation parameters within 7 days before randomization
- Voluntary agreement to participate with signed informed consent and ability to comply with treatment and follow-up
You will not qualify if you...
- Pregnant or breastfeeding women
- Conditions affecting oral medication intake such as swallowing difficulties, chronic diarrhea, or intestinal obstruction
- Known allergic reactions to study treatment components
- Peripheral neuropathy grade 2 or higher
- Serious infections like hepatitis B, C, HIV; recent heart attack; heart failure or significant arrhythmias
- Abnormal heart rate or ECG parameters
- Significant proteinuria or kidney issues
- Tumor invasion of major blood vessels or high risk of fatal bleeding
- Blood clot events within 6 months prior to enrollment
- Severe bleeding events or unhealed wounds or ulcers
- Uncontrolled fluid build-up requiring frequent drainage
- Previous malignancies within 5 years except certain skin or cervical cancers
- Participation in other antitumor drug trials within 4 weeks
- Other conditions deemed inappropriate for study participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Continued until disease progression, death, intolerable toxicity, or decision to discontinue
Participants receive albumin-bound paclitaxel alone or combined with either apatinib mesylate or bevacizumab to treat relapsed or metastatic triple-negative breast cancer.
Infusions once every 3 weeks; daily oral medication if assigned to apatinib group
Duration - Up to 2 years
Participants are monitored for progression-free survival, overall survival, response rates, adverse events, and biomarker levels for up to 2 years after treatment initiation.
Visit schedule varies for assessments during follow-up
Trial Site Locations
Total: 1 location
1
Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
Actively Recruiting
Research Team
J
Jing Liu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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