Compares albumin-bound paclitaxel (Ⅱ) with conventional albumin-bound paclitaxel in advanced breast cancer
Watches how albumin-bound paclitaxel (Ⅱ) works in adults with HER2-negative advanced breast cancer.
Plain-language title generated from the registry record
Registry title: Albumin-Bound Paclitaxel (Ⅱ) in Patients With Advanced Breast Cancer
Key facts
- Where
- Wuhan, ChinaSee the site
Where in China
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Trial code
- NCT07899047
- Record updated
- 27 October 2026
- Original description
This is a multicenter, prospective, observational real-world study. The study aims to evaluate the efficacy, safety and economic benefits of albumin-bound paclitaxel (Ⅱ) compared with conventional albumin-bound paclitaxel, in patients with HER2-negative advanced breast cancer.Read full original descriptionShow less
Efficacy, Safety, and Cost-Effectiveness of Albumin-Bound Paclitaxel (Ⅱ) in Chinese Patients With Advanced Breast Cancer: A Multicenter, Observational, Real-World Study
This is a multicenter, prospective, observational real-world study. The study aims to evaluate the efficacy, safety and economic benefits of albumin-bound paclitaxel (Ⅱ) compared with conventional albumin-bound paclitaxel, in patients with HER2-negative advanced breast cancer.
Inclusion: Aged ≥ 18 years; Histologically and/or cytologically confirmed HER2-negative recurrent or metastatic breast cancer (HER2-negative subtype includes HR-positive HER2-negative and triple-negative breast cancer); No restrictions on prior lines or regimens for recurrent/metastatic disease (e.g., endocrine therapy, CDK4/6 inhibitors, ADC agents, chemotherapy, immunotherapy, etc.). For patients previously exposed to taxane-based therapy in the neoadjuvant, adjuvant, or metastatic-disease setting, recurrence or disease progression must have occurred > 12 months after the last taxane administration; Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; At least one measurable lesion per RECIST version 1.1. Patients with bone-only metastases without measurable lesions are eligible; Planned to receive monotherapy or combination regimens containing either Paclitaxel for Injection (Albumin Bound) (Ⅱ) or paclitaxel for injection (albumin-bound). Combination partners include, but are not limited to, PD-1 inhibitors, capecitabine, gemcitabine, cisplatin, and carboplatin; Fully informed and voluntarily provides written informed consent for study participation.
Exclusion: Concurrent participation in other interventional clinical studies; Known hypersensitivity or intolerance to study drugs or their excipients; History of malignancies other than breast cancer within 5 years prior to the first study drug dose, except for cured malignancies such as in-situ carcinoma and basal-cell carcinoma; Uncontrolled third-space effusions (e.g., massive pleural, peritoneal, pericardial effusion) that cannot be stabilized (i.e., no further intervention required after drainage). Patients with small, asymptomatic pleural or peritoneal effusions identified by imaging are permitted; Active brain metastases (including symptomatic brain metastases or leptomeningeal metastases).