OncoMatch/Clinical Trials/NCT06143553
Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Metastatic Breast Cancer
Is NCT06143553 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for metastatic breast cancer (mbc).
Treatment: Paclitaxel Polymeric Micelles for · Eribulin Mesilate · Capecitabine Tablets · Gemcitabine Hydrochloride for · Vinorelbine Tartrate · Paclitaxel (albumin-bound) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (ihc 0 or 1+; or ihc 2+ and ish negative)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic chemotherapy or antibody-drug conjugate — metastatic
Subjects who are refractory or relapsed after ≥2 and ≤4 prior systemic chemotherapy regimens or antibody-drug conjugates (ADC) for MBC are eligible
Cannot have received: antibody-drug conjugate with anti-microtubule inhibitor payload
Previous use of antibody-drug conjugate (ADC) with anti-microtubule inhibitor as payload drug are not eligible
Cannot have received: antineoplastic drugs (including but not limited to chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy, surgery (except diagnostic biopsy), etc.)
Subjects who received antineoplastic drugs ... within 2 weeks before enrollment or who still have grade ≥2 toxicity from previous antineoplastic therapy (except alopecia and grade ≤2 neurotoxicity caused by platinum) at enrollment
Lab requirements
Blood counts
WBC ≥3.0x10^9/L; Neutrophil count ≥1.5x10^9/L; Platelet count ≥100x10^9/L; Hemoglobin ≥90g/L
Kidney function
Creatinine clearance (Cockcroft-Gault) ≥50 ml/min
Liver function
Total bilirubin ≤1.5x ULN; AST, ALT, or ALP ≤2.5x ULN (≤5x ULN for subjects with liver metastases, ALP ≤10x ULN for subjects with bone metastases)
Cardiac function
No symptoms of cardiac dysfunction (NYHA class ≤II) at baseline and no significant or clinically insignificant ECG abnormalities
Blood routine examination meets the following criteria ... Blood biochemical examination must meet the following criteria ... Subjects have no symptoms of cardiac dysfunction (NYHA class ≤II) at baseline and no significant or clinically insignificant ECG abnormalities
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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