Actively Recruiting
Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Metastatic Breast Cancer
Led by Shanghai Yizhong Pharmaceutical Co., Ltd. · Updated on 2024-11-29
168
Participants Needed
3
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, randomized, open, parallel positive control study compares the clinical efficacy and safety of paclitaxel polymeric micelles for injection with TPC in HER2- MBC subjects who have failed ≥2 to≤4 previous chemotherapy regimens. Treatment Protocol: Subjects are randomized into paclitaxel polymeric micelles for injection group and the Physician's Choice (TPC) group by the proportion of 1:1. Randomization is stratified according to three factors: number of lines of previous treatment for metastatic disease (2 or 3/4 lines), receptor status (triple-negative, non-triple-negative), and visceral metastasis (yes/no). Progression-free survival (PFS) is the main efficacy indicator in this study. Treatment Group: Subjects are given paclitaxel polymeric micelles for injection, three weeks constitutes one cycle of treatment. Control Group: Physician's Choice Group, subjects are given Eribulin Mesilate injection; or capecitabine tablets; or gemcitabine hydrochloride for injection; or vinorelbine tartrate injection; or paclitaxel (albumin-bound). Three or four weeks constitutes one cycle of treatment. If subject does not develop disease progression after 6 cycles of dosing, the subject continues treatment until disease progression (RECIST 1.1) or develops an intolerable toxicity, initiation of a new anti-cancer drug, withdrawal from the study, death, or loss of follow-up. Superiority design is used in this study, progression-free survival (PFS) is the main efficacy indicator. Assuming α = 0.0249(unilateral, adjusted test level), power=80%, the median PFS of the treatment group is 6.0 months, the median PFS of the control group is 3.7 months, the enrollment period is 12 months, and the study period is 24 months. Using PASS (version 11.0) for calculation, a total of 152 subjects (76 in each group) are required to meet the statistical significance between the treatment group and the control group. In consideration of case expulsion, enlarged by 10%, a total of 168 subjects (84 in each group) are required.
CONDITIONS
Official Title
Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Willing and able to understand the study and provide written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Confirmed HER2-negative metastatic breast cancer by recent biopsy from relapsed or metastatic sites
- Archival or new biopsy slides available from metastatic or recurrent sites (bone lesions excluded)
- Refractory or relapsed after 2 to 4 prior systemic chemotherapy regimens or antibody-drug conjugates for metastatic breast cancer
- Eligible to receive one of the chemotherapy regimens in the Physician's Choice group
- Measurable lesions on contrast-enhanced CT or MRI as per RECIST 1.1 criteria
- Normal major organ function including heart, lung, liver, and kidney
- Blood counts meeting specified minimum levels without recent transfusions or growth factors
- Blood biochemical tests within defined limits for bilirubin, liver enzymes, and kidney function
- No symptoms of cardiac dysfunction (NYHA class ≤ II) and no significant ECG abnormalities
- Good compliance and willingness to follow clinical trial protocol
- For women of childbearing age and men with reproductive potential, use of effective contraception and negative pregnancy test prior to enrollment
You will not qualify if you...
- Known allergy or intolerance to study treatments or their components
- Previous use of antibody-drug conjugates with anti-microtubule inhibitors
- Primary brain tumors or active central nervous system metastases except controlled single brain metastasis
- Uncontrolled infections or serious concurrent diseases
- History of other malignant tumors within the past 5 years (except certain skin and cervical cancers)
- Clinically significant chronic respiratory diseases within 6 months before enrollment
- Active inflammatory bowel disease or significant gastrointestinal conditions within 6 months
- Active hepatitis or liver metastases involving more than three-quarters of the liver
- Uncontrolled third-space fluid accumulations requiring intervention
- Mental illness, poor compliance, or inability to report treatment responses
- Severe organ dysfunction or failure that limits chemotherapy tolerance
- Bleeding disorders or history of organ transplant
- Substance abuse or infectious diseases like AIDS
- Long-term use of corticosteroids or immunosuppressants
- Recent vaccination within 4 weeks for certain vaccines or COVID-19 vaccine within 2 weeks
- Recent antineoplastic therapy within 2 weeks or unresolved toxicity from prior therapy
- Active hepatitis B or C infection or HIV positive status
- Investigator's judgment that participant cannot complete the trial or is unfit to participate
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Jiangsu province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
3
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
Research Team
X
Xiaoya Wang
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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