Actively Recruiting
Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
Led by Hebei Medical University Fourth Hospital · Updated on 2025-09-11
414
Participants Needed
1
Research Sites
461 weeks
Total Duration
On this page
Sponsors
H
Hebei Medical University Fourth Hospital
Lead Sponsor
B
Beijing 302 Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have \<1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease. The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.
CONDITIONS
Official Title
Nab-paclitaxel Plus Carboplatin Versus Nab-paclitaxel Plus Capecitabine in the Treatment of Advanced Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged between 18 and 70 years
- Histologically confirmed triple negative breast cancer
- No more than one prior treatment for locally advanced or metastatic breast cancer
- At least one measurable lesion according to RECIST criteria (version 1.1)
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Adequate bone marrow function: neutrophils ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥90 g/L
- Adequate renal and hepatic function: serum creatinine ≤1.5× institutional upper limit of normal (ULN); AST and ALT ≤2.5× ULN; total bilirubin ≤1.5× ULN, or ≤2.5× ULN if Gilbert's syndrome
- Good compliance with planned treatment, understanding of research process, and written informed consent
You will not qualify if you...
- Heart disease grade II or higher based on New York Heart Association (NYHA) scores
- Presence of brain metastasis
- Recurrence or metastasis within 6 months after stopping capecitabine
- Recurrence or metastasis within 6 months after stopping platinum treatment
- Progression, recurrence, or metastasis within 6 months after paclitaxel (including albumin paclitaxel) treatment
- Need for clinical intervention due to gastrointestinal bleeding, obstruction, or inability to feed
- Peripheral neuropathy grade 2 or higher
- Severe systemic infection or other serious illnesses
- Allergy or intolerance to chemotherapy drugs or their components
- Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer
- Pregnancy, breastfeeding, or refusal to use contraception during the trial for reproductive age patients
- Participation in any drug trial or other interventional clinical trial within 30 days before first dose
- Investigator judgment of unsuitability for enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
Research Team
C
Cuizhi Geng, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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