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.

NCT Number	NCT07393321
Lead Sponsor	Nanjing Chia-tai Tianqing Pharmaceutical
Conditions	HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer
Enrollment	210 participants
Start Date	2026-02-10
Primary Completion	2028-08-31 (estimated)
Study Completion	2031-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-06