A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Eribulin in Pretreated Advanced Triple-negative Breast Cancer Harboring a PIK3CA Mutation

Starting soon · Phase 2

Conditions studied: TNBC - Triple-Negative Breast Cancer, TNBC

In brief

This is an open-label, Simon's optimal two-stage design, single-arm, Phase II study with first 6 patients in the safety run-in portion. PIK3CAmut advanced triple-negative breast cancer(TNBC) patients who have progressed on at least one prior line of systemic therapy in advanced setting will be enrolled to receive inavolisib plus eribulin treatment. The study is carried out in two stages. In Stage One, 10 patients are accrued. If there are 4 or more responses among these 10 patients and positive recommendation by the safety review meeting based on the evaluation of first 6 safety run-in patients' data, additional 16 patients will be accrued in Stage Two, resulting in a total patient number of 26. Otherwise, the study will be terminated and a report will be prepared outlining the observed data and the rationale for termination.

Key facts

Study ID

NCT07441512

Run by

Hu Hai

People needed

26

Starts

2026-03-15

Expected to finish

2028-03-15

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet the following criteria for study entry:
• Signed Informed Consent Form
• Female participants who are at least 18 years of age on the day of signing informed consent
• Evaluable or measurable disease per RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of > 12 weeks
• Adequate hematologic and organ function within 14 days prior to initiation of study treatment, defined by the following:
• Absolute neutrophil count ≥ 1500/μL
• Hemoglobin ≥ 9 g/dL
• Platelet count ≥ 100,000/μL
• Fasting glucose < 126 mg/dL or < 7 mmol/L and glycosylated hemoglobin (HbA1C) < 6.5% or < 48 mmol/mol
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (< 3 × ULN if Gilbert's disease)
• Serum albumin ≥ 2.5 g/dL or 25 g/L
• AST and ALT ≤ 2.5 × ULN with the following exception:
• Patients with documented liver metastases: AST and ALT ≤ 5.0 × ULN
• o ALP ≤ 2.5 × ULN with the following exception:
• Participants with documented liver or bone metastases: ALP ≤ 5.0 × ULN
• o INR < 1.5 × ULN and aPTT < 1.5 × ULN
• For participants requiring anticoagulation therapy with warfarin or similar agents (such as Vitamin K antagonists), a stable INR between 2 and 3 is required. If anticoagulation is required for a prosthetic heart valve, then stable INR between 2.5 and 3.5 is permitted.
• Creatinine clearance ≥ 60 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation.
• Participants with controlled HBV infection are allowed if they have:
• Normal ALT levels
• Positive hepatitis B surface antigen (HbsAg) and negative total hepatitis B core antibody (HbcAb) or positive HbcAb and
• HBV DNA ≤ 2000 UI/mL
• They are under antiviral treatment following local guidelines. Prophylactic treatment and follow-up must be done by a specialized physician per local SoC. The overall potential benefits associated with study treatment should be deemed to exceed the overall risks by the investigator

You may not qualify if…

• Patients who meet any of the following criteria will be excluded from study entry:
• Pregnancy, lactation, or intention to become pregnant during the study
• o Women of childbearing potential (including those who have had a tubal ligation) must have a negative pregnancy test result within 14 days prior to initiation of study treatment.
• Metaplastic breast cancer
• Radiotherapy within 4 weeks before Cycle 1 Day 1
• Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
• Malabsorption syndrome or other condition that would interfere with enteral absorption
• Inability or unwillingness to swallow pills
• Any history of leptomeningeal disease or carcinomatous meningitis
• Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:
• Measurable or evaluable disease (per RECIST v1.1) outside the CNS
• No ongoing requirement for corticosteroids as therapy for CNS metastases, with corticosteroids discontinued for ≥ 2 weeks prior to enrollment and no ongoing symptoms attributed to CNS metastases
• Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
• The screening CNS radiographic study is ≥ 4 weeks since completion of radiotherapy
• No history of intracranial hemorrhage or spinal cord hemorrhage
• Pleural effusion, pericardial effusion, or ascites requiring drainage procedures every 14 days or more frequently
• o Indwelling pleural or abdominal catheters may be allowed, provided the patient has adequately recovered from the procedure, is hemodynamically stable and symptomatically improved.
• Symptomatic hypercalcemia requiring continued use of bisphosphonate or denosumab therapy
• o Bisphosphonate and denosumab therapy for bone metastases or osteopenia/osteoporosis is allowed.
• Any active infection that, in the opinion of the investigator, could impact patient safety; or serious infection requiring intravenous (IV) antibiotics within 7 days prior to Day 1 of Cycle 1
• Active inflammatory (e.g., uveitis or vitritis) or infectious (e.g., conjunctivitis, keratitis, scleritis, or endophthalmitis) conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
• Requirement for daily supplemental oxygen
• Symptomatic active lung disease that is not specifically due to underlying breast cancer, including pneumonitis
• Active tuberculosis
• History of or active inflammatory disease (e.g., Crohn's disease or ulcerative colitis), or any active bowel inflammation (including diverticulitis)

Full record on ClinicalTrials.gov

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