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A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes

15. september 2026 opdateret af: Hoffmann-La Roche

A Phase II Prospective, Open-Label Safety Study of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer and Type 2 Diabetes

This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Undersøgelse Kontakt Backup

  • Navn: Reference Study ID Number: GO45322 https://forpatients.roche.com/ No attachments to email below.
  • Telefonnummer: 888-662-6728 (U.S. and Canada)
  • E-mail: global-roche-genentech-trials@gene.com

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Type 2 diabetes with laboratory fasting blood glucose < 185 milligrams per deciliter (mg/dL) and HbA1c <= 8% on any stable anti-hyperglycemic regimen excluding insulin short-term insulin dosing
  • Eligible for triplet of inavolisib, fulvestrant and palbociclib: no prior systemic therapy for locally advanced unresectable or metastatic disease
  • Confirmed diagnosis of HR+/HER2- breast cancer
  • Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
  • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Adequate hematologic and organ function within 14 days prior to initiation of study treatment

Exclusion Criteria:

  • Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
  • Metaplastic breast cancer
  • Any history of Type 1 diabetes
  • Severe hyper- or hypoglycemia event within 6 months of initiation of study treatment
  • Any history of leptomeningeal disease or carcinomatous meningitis
  • Known and untreated, or active central nervous system (CNS) metastases Participants with a history of treated CNS metastases are eligible
  • Active inflammatory or conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
  • Symptomatic active lung disease
  • History of active bowel inflammation or active inflammatory bowel disease

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Inavolisib + Fulvestrant + Palbociclib
Participants will receive inavolisib and fulvestrant (and some participants palbociclib) as outlined in the intervention section.
Medicin: Inavolisib
Participants will receive oral inavolisib on Days 2-28 of each 28-day cycle.
Andre navne:
  • RO7113755
Medicin: Fulvestrant
Participants will receive intramuscular (IM) fulvestrant on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle.
Medicin: Palbociclib
Some participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of Participants With Grade 4 Hyperglycemia Adverse Events (AEs) After Cycle 1
Tidsramme: Up to approximately 21 months
Up to approximately 21 months
Percentage of Participants Hospitalized for Hyperglycemia or its Complications After Cycle 1
Tidsramme: Up to approximately 21 months
Up to approximately 21 months
Percentage of Participants with AEs After Cycle 1
Tidsramme: Up to approximately 21 months
Up to approximately 21 months

Sekundære resultatmål

Resultatmål
Tidsramme
Percentage of Particiants With Inavolisib-related Hyperglycemia AEs After Cycle 1
Tidsramme: Up to Cycle 1 (each cycle is 28 days)
Up to Cycle 1 (each cycle is 28 days)
Percentage of Participants With Inavolisib Discontinuations due to Hyperglycemia and its Complications
Tidsramme: Up to approximately 21 months
Up to approximately 21 months
Percentage of Participants With Inavolisib Dose Reduction due to Hyperglycemia
Tidsramme: Up to approximately 21 months
Up to approximately 21 months
Percentage of Participants With Return of Hemoglobin A1c or Glycated Hemoglobin (HbA1c) to Within 10% of Baseline Within 90 Days After Inavolisib Discontinuation
Tidsramme: Up to approximately 21 months
Up to approximately 21 months
Number of Participants Reporting Presence,Frequency,Severity,&/or Degree of Interference with Daily Function of Selected Symptomatic Treatment Toxicities Assessed by NCI Patient-Reported Outcomes Common Terminology Criteria for AEs (PRO-CTCAE)
Tidsramme: Up to approximately 21 months
Up to approximately 21 months
Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire
Tidsramme: Up to approximately 21 months
Up to approximately 21 months
Change from Baseline in Symptomatic Treatment-Related Toxicities as Assessed Through use of the PRO-CTCAE
Tidsramme: Baseline, Up to approximately 21 months
Baseline, Up to approximately 21 months
Change from Baseline in Treatment Side-Effect Bother as Assessed Through use of the FACT-G General Population, Question 5 (GP5) Item
Tidsramme: Baseline, Up to approximately 21 months
Baseline, Up to approximately 21 months
Objective Response Rate (ORR)
Tidsramme: Up to approximately 21 months
Up to approximately 21 months
Best Overall Response Rate (BOR)
Tidsramme: Up to approximately 21 months
Up to approximately 21 months
Duration of Response (DOR)
Tidsramme: Up to approximately 21 months
Up to approximately 21 months
Progression-Free Survival (PFS)
Tidsramme: Up to approximately 21 months
Up to approximately 21 months
Overall Survival (OS)
Tidsramme: Up to approximately 21 months
Up to approximately 21 months
Mean and Mean Change From Baseline in Physical Function Score as Assessed by European Organisation for Research and Treatment of Cancer Item Library 17 (EORTC-IL17)
Tidsramme: Baseline, up to approximately 21 months
Baseline, up to approximately 21 months
Mean and Mean Change From Baseline in Role Function Score as Assessed by EORTC-IL17
Tidsramme: Baseline, up to approximately 21 months
Baseline, up to approximately 21 months
Mean and Mean Change From Baseline in Health-Related Quality of Life (HRQoL) Score as Assessed by EORTC-IL17
Tidsramme: Baseline, up to approximately 21 months
Baseline, up to approximately 21 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hoffmann-La Roche

Efterforskere

  • Studieleder: Clinical Trials, Hoffmann-La Roche

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

30. oktober 2026

Primær færdiggørelse (Anslået)

15. juni 2029

Studieafslutning (Anslået)

30. september 2029

Datoer for studieregistrering

Først indsendt

20. juli 2026

Først indsendt, der opfyldte QC-kriterier

3. august 2026

Først opslået (Faktiske)

5. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GO45322

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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