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RECRUITING Phase 2 ClinicalTrials.gov

To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer

Sponsor: Hoffmann-La Roche • ClinicalTrials.gov ID: NCT07368998

Registry updated: 2026-10-06
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Description

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.

Interventions

  • Inavolisib (Drug)
    Participants will receive Inavolisib as per the schedule given in the protocol.
  • Fulvestrant (Drug)
    Participants will receive Fulvestrant as per the schedule given in the protocol.

Eligibility criteria

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

Conditions

Breast Cancer

Locations

  • Los Angeles Cancer Network — Los Angeles, California, United States
  • Cancer Specialists of North Florida — Jacksonville, Florida, United States
  • HCA Midwest Division — Kansas City, Missouri, United States
  • Astera Cancer Care East Brunswick — East Brunswick, New Jersey, United States
  • Instituto de Oncologia de Rosario — Rosario, Santa Fe Province, Argentina
  • Centro Oncologico Korben — Ciudad Autonoma Buenos Aires, Argentina
  • Hospital Privado - Centro Medico de Córdoba — Córdoba, Argentina
  • Centro Oncologico Riojano Integral (CORI) — La Rioja, Argentina
  • Hospital Provincial del Centenario — Rosario, Argentina
  • Centro Oncológico de Excelencia — San Juan, Argentina
  • Blacktown Hospital — Blacktown, New South Wales, Australia
  • Coffs Harbour Health Campus — Coffs Harbour, New South Wales, Australia
  • Bendigo Cancer Centre — Bendigo, Victoria, Australia
  • Sir Charles Gairdner Hospital — Perth, Western Australia, Australia
  • Cliniques Universitaires St-Luc — Brussels, Belgium
  • Jessa Zkh (Campus Virga Jesse) — Hasselt, Belgium
  • UZ Leuven Gasthuisberg — Leuven, Belgium
  • Clinique Ste-Elisabeth — Namur, Belgium
  • Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara, Jalisco, Mexico
  • RENATI INNOVATION S.A.P.I. de C.V — Guadalajara, Jalisco, Mexico
  • Centro de Infusion Tratamiento e Investigacion Oncologica S DE R — Queretaro Qro, Querétaro, Mexico
  • CENEIT Oncologicos — Mexico City, Mexico
  • Hospital Universitari Vall d'Hebron;Oncology — Barcelona, Spain
  • Hospital Universitario San Cecilio — Granada, Spain
  • Hospital Universitario 12 De Octubre — Madrid, Spain
  • Hospital Clinico Universitario de Valencia — Valencia, Spain
  • Bagcilar Medipol Mega Universitesi Hastanesi — Bağcılar, Istanbul, Turkey (Türkiye)
  • Adana Baskent University Hospital — Adana, Turkey (Türkiye)
  • Memorial Ankara Hastanesi — Ankara, Turkey (Türkiye)
  • Medical Park Seyhan Hospital — Seyhan, Turkey (Türkiye)
  • Blackpool Victoria Hospital — Blackpool, United Kingdom
  • Princess Alexandra Hospital — Harlow, United Kingdom
  • Mount Vernon Cancer Centre — Northwood, Middlesex, United Kingdom
  • Churchill Hospital - Oxford Cancer & Haematology Centre — Oxford, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record