Status: Not yet recruiting
A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer
NTQ1062-301 is a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of the small-molecule AKT inhibitor NTQ1062 combined with fulvestrant versus placebo combined with fulvestrant in patients with HR positive, HER2 negative, locally advanced (unresectable) or metastatic breast cancer that has recurred or progressed during or after endocrine therapy and harbors PIK3CA/AKT1/PTEN alterations.
Participants needed: 210
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Nanjing Chia-tai Tianqing PharmaceuticalUpdated: Feb 6, 2026
Eligibility criteria
(1) Adult female or male subjects who sign the informed consent form and are at...
unsuitable for endocrine anti-tumor therapy by the investigators, such as sympto... [+20]