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Compares treatment options for Breast Cancer
Official title A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
ClinicalTrials.gov ID: NCT06790693
What this study is testing
What is Inavolisib?
Inavolisib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer.
Also referred to as GDC-0077, Itovebi.
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
- This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
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
- Women or men with histologically or cytologically confirmed carcinoma of the breast
- Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American...
- Documented HER2-negative tumor according to ASCO/CAP guidelines
- De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy...
- Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
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 prior systemic therapy for locally advanced unresectable or metastatic breast cancer
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Any history of leptomeningeal disease or carcinomatous meningitis
- Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible
See the full eligibility criteria
- Women or men with histologically or cytologically confirmed carcinoma of the breast
- Documented ER-positive and/or progesterone receptor-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- Documented HER2-negative tumor according to ASCO/CAP guidelines
- De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant/adjuvant endocrine therapy without disease progression during that treatment and disease-free interval...
- Participants who have bilateral breast cancers which are both HR-positive and HER2-negative
- Confirmation of biomarker eligibility
- Consent to provide fresh or archival tumor tissue specimen
- Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 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 prior systemic therapy for locally advanced unresectable or metastatic breast cancer
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
- Any history of leptomeningeal disease or carcinomatous meningitis
- Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible
- Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
- Symptomatic active lung disease
- History of or active inflammatory bowel disease
- Any active bowel inflammation
- Prior hematopoietic stem cell or bone marrow transplantation
- Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Burbank, California, United States
- La Jolla, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Marcos, California, United States
- San Mateo, California, United States
- Sunnyvale, California, United States
- Jacksonville, Florida, United States
- Tallahassee, Florida, United States
- Tampa, Florida, United States
- Weston, Florida, United States
- Marietta, Georgia, United States
- O'Fallon, Illinois, United States
- Springfield, Illinois, United States
- Urbana, Illinois, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Annapolis, Maryland, United States
+ 177 more site(s).
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 - 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?
Study sites include Phoenix, Arizona, United States; Burbank, California, United States; La Jolla, California, United States; Los Alamitos, California, United States; Los Angeles, California, United States; Palo Alto, California, United States and 191 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.