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

NCT07441512 | Not Yet Recruiting Phase 2

• 1 other identifier: ML46206
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

TNBC - Triple-Negative Breast Cancer; TNBC

Keywords

ML46206; TNBC

Outcome Measures

Primary Outcomes (1)

• ORR by Investigator assessment per RECIST 1.1

  ORR by Investigator assessment per RECIST 1.1

  22 months

Secondary Outcomes (8)

• Incidence and severity of adverse events (graded by CTCAE v5.0)

  22 months

• Number of participants with Abnormal and clinically significant change from baseline in targeted vital signs

  22 months

• Number of participants with Abnormal and clinical significant change from baseline in targeted clinical laboratory test results

  22 months

• Secondary Outcome Measure

  22 months

• PFS by Investigator assessment per RECIST 1.1

  22 months

Study Arms (1)

A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With E

EXPERIMENTAL

All enrolled patients will receive inavolisib 9 mg once daily (QD) with eribulin (1.4 mg/m2 IV days 1 and 8), both administered every 21 days until RECIST 1.1-defined progression or another discontinuation criterion is met.Following treatment discontinuation, choice of subsequent therapy will be at the discretion of the Investigator.

Drug: Inavolisib in Combination With Eribulin

Interventions

Inavolisib in Combination With Eribulin DRUG

All enrolled patients will receive inavolisib 9 mg once daily (QD) with eribulin (1.4 mg/m2 IV days 1 and 8), both administered every 21 days until RECIST 1.1-defined progression or another discontinuation criterion is met. Following treatment discontinuation, choice of subsequent therapy will be at the discretion of the Investigator.

A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With E

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Hu Hai: lead
• Zhejiang Cancer Hospital: collaborator

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

inavolisib; eribulin

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hai Hu Doctor

CONTACT

86+15958192550; hjoyh@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 2, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02