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RecruitingPhase 2

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 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of inavolisib and fulvestrant, with or without palbociclib. It is for people with advanced breast cancer and type 2 diabetes. The cancer must have a PIK3CA gene change, use hormones to grow (HR+), and not have high levels of the HER2 protein (HER2-negative).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have type 2 diabetes with fasting blood sugar below 185 mg/dL and HbA1c, a measure of average blood sugar, at 8% or lower. Diabetes treatment must be stable; insulin restrictions apply.
  • For the three-drug treatment, have had no prior whole-body cancer treatment for cancer that has spread or cannot be removed by surgery.
  • Have confirmed HR-positive, HER2-negative breast cancer.
  • Have a required PIK3CA gene change found by a required test.
  • Have cancer that can be measured using the study’s rules.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Have blood counts and organ function that meet study requirements, checked within 14 days before treatment starts.

Who can't join

  • Are pregnant, breastfeeding, or planning pregnancy during the study or while birth control is required.
  • Have metaplastic breast cancer, a specific type of breast cancer.
  • Have ever had type 1 diabetes, or had severely high or low blood sugar within 6 months before study treatment.
  • Have ever had cancer in the tissues covering the brain or spinal cord.
  • Have untreated or active cancer spread to the brain or spinal cord. People with previously treated spread may join.
  • Have active eye inflammation or another active eye condition, or past uveitis (inflammation inside the eye) with no known cause or linked to the immune system.
  • Have active lung disease that causes symptoms.
  • Have a history of bowel inflammation or currently have inflammatory bowel disease.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (9)

DC

GA

NE

NY

WV