NCT07393321

A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer

A Randomized, Double-blind, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of NTQ1062 in Combination With Fulvestrant Versus Placebo Plus Fulvestrant in Patients With Locally Advanced (Unresectable) or Metastatic HR+/HER2- Breast Cancer Who Relapsed or Progressed During or After Endocrine Therapy.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Placebo + fulvestrant	Placebo: 200 mg orally twice daily, for 21 consecutive days, followed by 7 days off (21/7 dosing schedule), during a 28-day cycle. Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 and Day 15 of cycle 1, and then on Day 1of each cycle thereafter.
DRUG	NTQ1062+Fulvestrant	NTQ1062: 200 mg orally twice daily, for 21 consecutive days, followed by 7 days off (21/7 dosing schedule), during a 28-day cycle. Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 and Day 15 of cycle 1, and then on Day 1of each cycle thereafter.

Timeline

• Start date: 2026-02-10
• Primary completion: 2028-08-31
• Completion: 2031-08-31
• First posted: 2026-02-06
• Last updated: 2026-02-06