Biostar registers Phase 3 pitting Utidelone capsule against its own injection
The China-only trial tests a formulation switch, not a new mechanism, with no posted primary endpoint threshold and enrollment not yet started.
Executive Summary
- Beijing Biostar Pharmaceuticals Co., Ltd. registered a Phase 3 trial, NCT07684456, comparing its own Utidelone capsule against its own Utidelone injection, both paired with capecitabine, in 308 patients with HER2-negative advanced breast cancer NCT07684456Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast CancerNCT07684456.
- The comparator is the sponsor's already-marketed injectable formulation, not a third-party drug or a different standard of care, which frames this as a formulation-bridging study rather than a new efficacy claim.
- This is the ninth Utidelone trial in breast cancer the sponsor runs concurrently, including a Phase 3 head-to-head against docetaxel and another against taxane-based regimens, which limits how much new information any single registration adds.
- The registry does not disclose the PFS non-inferiority margin, statistical plan, or comparator threshold, and the trial has not begun enrolling, so no operational or efficacy signal exists yet to grade.
- The Beta-Tubulin target shows declining field activity, 68 recent trials against 1,325 older ones, in a Breast Cancer landscape the model scores as 'challenging'.
The registration
ClinicalTrials.gov added NCT07684456 on July 6, 2026, registering a randomized Phase 3 trial of Utidelone Capsule plus capecitabine against Utidelone Injection plus capecitabine in 308 patients with HER2-negative advanced, recurrent, or metastatic breast cancer NCT07684456Efficacy and Safety of Utidelone Capsule and Utidelone Injection in Patients With HER-2 Negative Advanced Breast CancerNCT07684456. The trial is not yet recruiting, with a planned start date of August 1, 2026, and a primary completion date of March 1, 2028. The registered primary endpoint is progression-free survival, assessed on a 6-week time frame per the outcome listing, though the non-inferiority or superiority margin is not disclosed.
What's at stake
The comparator arm is the sponsor's own marketed Utidelone injection, not a rival drug or a different chemotherapy backbone, which signals the study is designed to bridge an oral capsule formulation to the existing injectable rather than to test a new therapeutic hypothesis. Eligible patients must have received at least one prior taxane or anthracycline regimen, placing this squarely in the second-line-plus setting, and patients with CNS metastases or grade 2-plus peripheral neuropathy are excluded.
A crowded own-pipeline
Beijing Biostar Pharmaceuticals Co., Ltd. already runs eight other Utidelone trials in breast cancer, including NCT05430399 (Utidelone versus docetaxel, Phase 3, recruiting), NCT05172518 (Utidelone plus capecitabine versus taxane plus capecitabine, Phase 3, primary completion March 2027) and NCT06764940 (a Phase 2 study in patients with brain metastases). The sponsor's completion rate across four prior trials is 100%, with zero terminations recorded, which supports operational credibility even as it does not resolve what this specific formulation study will show.
The mechanism context
Utidelone is a Beta-Tubulin-targeted microtubule stabilizer, a small-molecule class also used by paclitaxel and the antibody-drug conjugate trastuzumab emtansine, both of which the dossier flags as readthrough comparators rather than direct rivals because they sit in different indications or modalities. No trial in the competitive-context comparator set qualifies as an eligible direct comparator: every other Phase 3 Breast Cancer asset named, including ribociclib, giredestrant, camizestrant, and elacestrant, works through a different target. The Beta-Tubulin field itself is losing momentum, with recent trial activity at 68 studies against 1,325 older ones, a decline the landscape model scores at 0.951 on its normalized scale.
Timeline risk
The trial's planned duration runs 976 days from an August 2026 start to a March 2029 full completion, with primary completion set for March 2028. Because enrollment has not started, the trial carries the ordinary risk profile of any not-yet-recruiting Phase 3 study in a landscape the model already labels 'challenging,' with a landscape score of 55. No CT.gov results are posted, and the readout-forecast model returned no prediction row for this trial, leaving timing confidence dependent entirely on the registered dates rather than any independent model check.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.