OncoMatch/Clinical Trials/NCT06419621
PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC
Is NCT06419621 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including PM8002 and Nab-Paclitaxel for triple negative breast cancer(tnbc).
Treatment: PM8002 · Nab-Paclitaxel — This multicenter, randomized, double-blind study will evaluate the safety and efficacy of PM8002 in combination with Nab-Paclitaxel compared with placebo combined with Nab-Paclitaxel as first-line treatment in inoperable locally advanced/metastatic triple-negative breast cancer(TNBC)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (negative)
Required: ESR1 negative (negative)
Required: PR (PGR) negative (negative)
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: immune checkpoint agonist
Previous treatment with immune checkpoint agonists (such as CD137 agonists)
Cannot have received: immune checkpoint inhibitor
immune checkpoint inhibitors (such as CTLA-4, PD-1, PD-L1, LAG3 monoclonal antibody, etc.)
Cannot have received: anti-vascular endothelial growth factor (VEGF) target drugs
anti-vascular endothelial growth factor (VEGF) target drugs
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06419621 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 negative is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR negative is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify