Trial studying safety and effects for Breast Cancer
Official title A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
ClinicalTrials.gov ID: NCT07748208
What this study is testing
What is Inavolisib?
This is an investigational oral medicine being studied as a potential treatment for breast cancer. It is designed to block a specific protein pathway that helps cancer cells grow.
Also referred to as RO7113755.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how safe the drug combination is for patients whose breast cancer has a PIK3CA mutation and who also have type 2 diabetes.
- Who it's for
- Adults with advanced, hormone‑receptor positive, HER2‑negative breast cancer that has a PIK3CA mutation and who have type 2 diabetes.
- What's involved
- Participants will receive the study drugs and have regular clinic visits for monitoring and blood tests to check safety.
- Time commitment
- The study lasts several months, with multiple scheduled visits for drug administration and safety assessments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Type 2 diabetes with laboratory fasting blood glucose \< 185 milligrams per deciliter (mg/dL) and HbA1c \<= 8% on any stable anti-hyperglycemic...
- 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)
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Grand Island, Nebraska, United States
- Omaha, Nebraska, United States
- Mineola, New York, United States
- New York, New York, United States
- Morgantown, West Virginia, United States
- Dorado, Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Washington D.C., District of Columbia, United States; Atlanta, Georgia, United States; Grand Island, Nebraska, United States; Omaha, Nebraska, United States; Mineola, New York, United States; New York, New York, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.