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NCT Number: NCT07748208

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Type II Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inavolisib

Drug

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

Other names: RO7113755

Fulvestrant

Drug

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.

Palbociclib

Drug

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

Primary outcomes

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

    Time frame: Up to approximately 21 months

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

    Time frame: Up to approximately 21 months

  3. Percentage of Participants with AEs After Cycle 1

    Time frame: Up to approximately 21 months

Secondary outcomes

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

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

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

    Time frame: Up to approximately 21 months

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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: Up to approximately 21 months

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

    Time frame: 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

    Time frame: Baseline, Up to approximately 21 months

  9. Objective Response Rate (ORR)

    Time frame: Up to approximately 21 months

  10. Best Overall Response Rate (BOR)

    Time frame: Up to approximately 21 months

  11. Duration of Response (DOR)

    Time frame: Up to approximately 21 months

  12. Progression-Free Survival (PFS)

    Time frame: Up to approximately 21 months

  13. Overall Survival (OS)

    Time frame: 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)

    Time frame: Baseline, up to approximately 21 months

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

    Time frame: 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

    Time frame: Baseline, up to approximately 21 months

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

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

CONTACT

[email protected]

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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