PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC

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)

Trial Details

NCT ID
NCT06419621
Phase
PHASE3
Sponsor
Biotheus Inc.
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • PM8002
  • Nab-Paclitaxel
  • Placebo
Locations (sample)
  • Bengbu, Anhui, China|32.94083,117.36083
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Fuzhou, Fujian, China|26.06139,119.30611
  • Lanzhou, Gansu, China|36.05701,103.83987

Key Eligibility Criteria

  • Ability to understand and willing to provide written informed consent and to comply with scheduled visits and study procedures;
  • Female, aged 18 to 70 years (inclusive);
  • Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2. Testing results for …
  • Subjects who have not received prior systemic treatment(except endocrine therapy) for advanced breast cancer are eligible for the study. Subjects w…

For full eligibility, visit ClinicalTrials.gov.

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