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RecruitingInterventionalPhase 2

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

NCT ID: NCT07368998Sponsor: Hoffmann-La RocheLast updated: 2026-06-09

Summary

The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.

Arms & interventions

  • DrugInavolisib

    Participants will receive Inavolisib as per the schedule given in the protocol.

  • DrugFulvestrant

    Participants will receive Fulvestrant as per the schedule given in the protocol.

Outcome measures

Primary

  • Percentage of Participants With Objective Response Rate (ORR)

    Time frame: Up to approximately 2 years

  • Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 2 years

Secondary

  • Duration of Response (DOR)

    Time frame: Up to approximately 2 years

  • Time to Response (TTR)

    Time frame: Up to approximately 2 years

  • Progression-free Survival (PFS)

    Time frame: Up to approximately 2 years

  • Percentage of Participants With Treatment Discontinuation due to Adverse Events

    Time frame: Up to approximately 2 years

  • Number of Participants Reporting Presence, Frequency, Severity and/or Degree of Interference With Daily Activities of Symptomatic Treatment Toxicities as Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)

    Time frame: Up to approximately 2 years

  • Percentage of Participants Reporting Presence and Frequency of Selected Hyperglycemia Symptoms as Assessed by European Organisation for Research and Treatment of Cancer (EORTC) IL382

    Time frame: Up to approximately 2 years

  • Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item General Population, Question 5 (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire

    Time frame: Up to approximately 2 years

  • Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE

    Time frame: Baseline, Up to approximately 2 years

  • Change from Baseline in Selected Hyperglycemia Symptoms as Assessed by EORTC IL382

    Time frame: Baseline, Up to approximately 2 years

  • Change from Baseline in Treatment Side-effect Bother as Assessed Through use of the FACT-G GP5 Item

    Time frame: Baseline, Up to approximately 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Documented ER +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: \<= 1 prior lines of systemic therapy in the locally advanced (recurrent or progressed) or metastatic setting * Measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) * Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines * Confirmation of biomarker eligibility: presence of \>= 1 study-eligible PIK3CA mutation * Life expectancy of \> 6 months * Ability, in the investigator's judgment, and willingness to comply with all study -related procedures, including completion of patient-reported outcomes Exclusion Criteria: * Metaplastic breast cancer * Prior treatment with chemotherapy in the recurrent locally advanced/metastatic setting * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Prior treatment with PI3K/Akt/mTOR inhibitors in the recurrent locally advanced/metastatic setting * Requirement for daily supplemental oxygen * Symptomatic active lung disease, including pneumonitis

Study locations (2)

Los Angeles Cancer Network

Los Angeles, California, 90017-4803

Recruiting

Astera Cancer Care East Brunswick

East Brunswick, New Jersey, 08816

Recruiting