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

NCT07393321 | Not Yet Recruiting Phase 3

• 1 other identifier: NTQ1062-301
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) as assessed by investigators according to RECIST v1.1

  Progression-free survival (PFS) as assessed by investigators according to RECIST v1.1, defined as the time from randomization to the date of disease progression or death from any cause.

  From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.

Secondary Outcomes (5)

• PFS assessed by BICR according to RECIST v1.1.

  From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.

• Overall survival (OS) defined as the time from randomization to the date of death from any cause.

  From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.

• Duration of response (DoR), defined as the time from the date of first recorded response to the date of documented disease progression or the date of death in the absence of documented progression.

  From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter

• Disease control rate (DCR), defined as the percentage of subjects achieving CR, PR, or stable disease (SD) per RECIST v1.1

  From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.

• Clinical benefit rate (CBR), defined as the percentage of patients achieving CR, PR, or stable disease (without subsequent anticancer therapy) per RECIST v1.1

  From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.

Study Arms (2)

placebo+ fulvestrant

PLACEBO COMPARATOR

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: Placebo + fulvestrant

NTQ1062+fulvestrant

EXPERIMENTAL

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 Day15 of cycle 1, and then on Day 1 of each cycle thereafter.

Drug: NTQ1062+Fulvestrant

Interventions

Placebo + fulvestrant DRUG

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.

placebo+ fulvestrant

NTQ1062+Fulvestrant DRUG

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.

NTQ1062+fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• unsuitable for endocrine anti-tumor therapy by the investigators, such as symptomatic visceral crises or inflammatory breast cancer that may be life-threatening in the short term;
• unable to take oral medication, or with severe gastrointestinal disorders that may affect drug absorption, such as intractable nausea and vomiting, chronic diarrhea (diarrhea lasting \>4 weeks), or intestinal obstruction;
• clinically significant glucose metabolism abnormalities, defined as: diagnosed with type 1 diabetes; type 2 diabetes requiring insulin treatment; glycated hemoglobin (HbA1c) ≥8%; fasting blood glucose \>9.3 mmol/L in patients with history of type 2 diabetes, or fasting blood glucose \>7.0 mmol/L in patients without history of diabetes;
• prior use of fulvestrant or other selective estrogen receptor degraders (SERDs) or any PI3K/mTOR/Akt inhibitors;
• other malignancies besides breast cancer within 5 years prior to screening (excluding basal or squamous cell skin cancer, papillary thyroid carcinoma, bladder carcinoma in situ, or cervical carcinoma in situ, or other tumors that have been radically treated and have shown no clinical recurrence for at least 5 years);
• have undergone major surgery within 28 days prior to the first dose;
• have participated in other interventional clinical studies of unmarketed products within 28 days prior to the first dose;
• severe infections requiring systemic intravenous antibiotics within 28 days prior to the first dose;
• have received \>30% bone marrow radiotherapy or extensive radiotherapy within 28 days prior to the first dose, or palliative local radiotherapy (such as thoracic spine and rib radiotherapy) within 14 days prior to the first dose;
• have received chemotherapy, endocrine therapy, CDK4/6 inhibitors, traditional Chinese medicine with clear anti-tumor indications, or other small molecule targeted anti-tumor drugs within 14 days prior to the first dose or within 5 half-lives of the drug (whichever is shorter);
• Received potent CYP3A inhibitors or potent CYP3A inducers within 14 days before the first dose;
• Known active central nervous system (CNS) metastases, including symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression. Patients who are asymptomatic or stable after treatment and do not require steroid treatment are eligible for enrollment, provided that imaging studies during the screening period confirm no progression for at least 4 weeks;
• History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease;
• History of severe cardiovascular or cerebrovascular disease;
• active hepatitis, defined as positive for hepatitis B surface antigen (HBsAg) and HBV DNA titer above the local laboratory's lower limit of detection; or positive for hepatitis C virus (HCV) antibody and HCV RNA above the local laboratory's lower limit of detection;

Sponsors & Collaborators

• Nanjing Chia-tai Tianqing Pharmaceutical: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 6, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2031
• Last Updated: February 6, 2026

Record last verified: 2026-01