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

NCT07393321 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-02-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Nanjing Chia-tai Tianqing Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2028-08-31
Completion
2031-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07393321 on ClinicalTrials.gov