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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

ConditionsBreast CancerDiabetes Type II
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Inavolisib

    Drug

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

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Inavolisib + Fulvestrant + PalbociclibExperimental treatment 3 interventions

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: