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.
(1) Adult female or male subjects who sign the informed consent form and are at least 18 years of age at the time of signing; (2) pre- and/or post-menopausal women are eligible for inclusion. Premenopausal women must receive ovarian function suppression treatment during the study, such as gonadotropin-releasing hormone agonists (GnRHa). Menopause is defined as: prior bilateral oophorectomy; age ≥ 60 years; age < 60 years, with amenorrhea for ≥ 12 months without prior chemotherapy, tamoxifen, toremifene, or ovarian suppression therapy, and follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal reference range; (3) Histologically confirmed HR positive, HER-2-negative recurrent locally advanced or metastatic breast cancer, as determined by testing of a recent tumor sample; (4) Prior treatment with at least one endocrine therapy regimen (monotherapy or combination therapy, including aromatase inhibitors and selective ER modulators); (5) Subjects must have at least one measurable disease lesion assessable by CT or MRI, or at least one osteolytic or mixed (osteolytic + sclerotic) bone lesion at baseline; (6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; (7) No contraindications to fulvestrant, and meets the eligibility requirements for fulvestrant treatment, as assessed by the investigator; (8) Expected survival time of more than 6 months, as assessed by the investigator; (9) Good bone marrow reserve and organ function; (10) Premenopausal women must have a negative pregnancy test before administration and agree to use effective contraception during the trial and for at least 6 months after the last dose.
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;
Parallel
Placebo + fulvestrant
DrugPlacebo: 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
DrugNTQ1062: 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.
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.
PFS assessed by BICR according to RECIST v1.1.
PFS assessed by BICR according to RECIST v1.1.
Overall survival (OS) defined as the time from randomization to the date of death from any cause.
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.
Disease control rate (DCR), defined as the percentage of subjects achieving CR, PR, or stable disease (SD) per RECIST v1.1
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