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Breast CancerPhase 2NCT07748208

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

A Phase 2 study testing Inavolisib, Fulvestrant and Palbociclib in people with Breast Cancer and Diabetes Type II, run by Hoffmann-La Roche at 10 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Diabetes Type II
What is being tested?
Inavolisib, Fulvestrant and Palbociclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
10 sitesin 2 countries
Study dates
30 Oct 2026to 30 Sep 2029
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: GO45322 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

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

10 sites in 2 countries

United States9 sites, 9 recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303-3031

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308-2212

    Recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Recruiting

  • Nebraska Cancer Specialists St Francis - Grand Island

    Grand Island, Nebraska, 68803

    Recruiting

  • NYU Langone Hospital Long Island Clinical Research

    Mineola, New York, 11501-4089

    Recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506-1200

    Recruiting

  • NYU Langone?s Perlmutter Cancer Center - 160 E 34th St

    New York, New York, 10016-4744

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68114

    Recruiting

  • MedStar Washington Hosp Center

    Washington D.C., District of Columbia, 20010

    Recruiting

Other trials in United States

Puerto Rico1 site, 1 recruiting

  • Pan American Center for Oncology Trials, LLC

    Dorado, 00646-2202

    Recruiting

Other trials in Puerto Rico

About this study

Official title: 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.

Being tested
Inavolisib, Fulvestrant, Palbociclib
Medical subject headings
Breast Neoplasms, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InavolisibDrug

    Also called RO7113755

    Participants will receive oral inavolisib on Days 2-28 of each 28-day cycle.

  • FulvestrantDrug

    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.

  • PalbociclibDrug

    Some participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

Study groups in NCT07748208
Study groupRoleWhat they receive
Inavolisib + Fulvestrant + PalbociclibExperimentalParticipants will receive inavolisib and fulvestrant (and some participants palbociclib) as outlined in the intervention section.
Receives: Drug: Inavolisib; Drug: Fulvestrant; Drug: Palbociclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Grade 4 Hyperglycemia Adverse Events (AEs) After Cycle 1

    Measured: Up to approximately 21 months

  2. Percentage of Participants Hospitalized for Hyperglycemia or its Complications After Cycle 1

    Measured: Up to approximately 21 months

  3. Percentage of Participants with AEs After Cycle 1

    Measured: Up to approximately 21 months

Secondary outcomes (16)

  1. Percentage of Particiants With Inavolisib-related Hyperglycemia AEs After Cycle 1

    Measured: Up to Cycle 1 (each cycle is 28 days)

  2. Percentage of Participants With Inavolisib Discontinuations due to Hyperglycemia and its Complications

    Measured: Up to approximately 21 months

  3. Percentage of Participants With Inavolisib Dose Reduction due to Hyperglycemia

    Measured: Up to approximately 21 months

  4. Percentage of Participants With Return of Hemoglobin A1c or Glycated Hemoglobin (HbA1c) to Within 10% of Baseline Within 90 Days After Inavolisib Discontinuation

    Measured: Up to approximately 21 months

  5. 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)

    Measured: Up to approximately 21 months

  6. 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

    Measured: Up to approximately 21 months

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

    Measured: Baseline, Up to approximately 21 months

  8. Change from Baseline in Treatment Side-Effect Bother as Assessed Through use of the FACT-G General Population, Question 5 (GP5) Item

    Measured: Baseline, Up to approximately 21 months

  9. Objective Response Rate (ORR)

    Measured: Up to approximately 21 months

  10. Best Overall Response Rate (BOR)

    Measured: Up to approximately 21 months

  11. Duration of Response (DOR)

    Measured: Up to approximately 21 months

  12. Progression-Free Survival (PFS)

    Measured: Up to approximately 21 months

  13. Overall Survival (OS)

    Measured: Up to approximately 21 months

  14. 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)

    Measured: Baseline, up to approximately 21 months

  15. Mean and Mean Change From Baseline in Role Function Score as Assessed by EORTC-IL17

    Measured: Baseline, up to approximately 21 months

  16. Mean and Mean Change From Baseline in Health-Related Quality of Life (HRQoL) Score as Assessed by EORTC-IL17

    Measured: Baseline, up to approximately 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion15 Jun 2029 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07748208
Sponsor's protocol ID
GO45322
Status last verified
Oct 2026
First submitted
20 Jul 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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