A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
New Breast Cancer Drug Trial: Inavolisib Plus Standard Treatment
Plain English Summary
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 is a Phase 3 clinical trial sponsored by Hoffmann-La Roche studying Breast Cancer. This trial tests if a new drug, inavolisib, when added to standard treatment (a CDK4/6 inhibitor and letrozole), is better than placebo plus standard treatment for advanced breast cancer. It is for patients with a specific type of advanced breast cancer that is hormone-receptor positive, HER2-negative, and has a PIK3CA mutation. Participation involves receiving either inavolisib or a placebo along with standard treatment, with regular check-ups and tests. Alternatives include standard treatment alone or other therapies approved for this type of breast cancer, depending on prior treatments and disease progression. The trial aims to enroll 450 participants.
Official Summary
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).
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with newly diagnosed or relapsed advanced breast cancer that is hormone-receptor positive and HER2-negative, and has a PIK3CA mutation. Patients must have measurable disease and a good general health status (ECOG 0 or 1). Patients who are pregnant, breastfeeding, have certain types of breast cancer (e.g., metaplastic), or have active brain metastases cannot join. Individuals with a history of treated brain metastases may be eligible, but active or untreated brain metastases are an exclusion. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome, Progression-Free Survival, measures how long patients live without their cancer getting worse or dying, indicating how effective the new drug combination is at controlling the dis The specific primary outcome measures are: Progression-Free Survival (PFS) (From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial addresses a significant unmet need in advanced breast cancer by investigating a novel targeted therapy that aims to improve outcomes for patients with specific genetic mutations. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
This trial targets a specific subset of advanced breast cancer, representing a significant market opportunity if successful, with potential for improved efficacy over existing therapies. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor about the specific CDK4/6 inhibitor and letrozole you would receive, and how inavolisib or placebo is administered. Be prepared for regular clinic visits for blood tests, scans to check your cancer, and to report any side effects. The study involves taking oral medications daily and potentially for extended periods, depending on disease response. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 450 participants
Interventions
- DRUG: Inavolisib — Participants will receive oral inavolisib once daily (QD).
- DRUG: Placebo — Participants will receive oral placebo QD.
- DRUG: CDK4/6i — Participants will receive CDK4/6i on either Days 1-21 or Days 1-28 of each 28-day cycle.
- DRUG: Letrozole — Participants will receive oral letrozole QD.
Primary Outcomes
- Progression-Free Survival (PFS) (From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years))
Secondary Outcomes
- Overall Survival (OS) (From randomization to death from any cause (up to 7 years))
- Investigator-assessed Objective Response Rate (ORR) (Up to 7 years)
- Investigator-assessed Duration of Response (DOR) (From the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years))
- Investigator-assessed Clinical Benefit Rate (CBR) (Up to 7 years)
- Time to Confirmed Deterioration (TTCD) in Pain (From baseline until end of follow-up (up to 7 years))
Full Eligibility Criteria
Inclusion 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 of at least 1 year since the completion of that treatment * 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 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 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
Trial Locations
- Disney Family Cancer Center, Burbank, California, United States
- Scripps Health, La Jolla, California, United States
- Cancer and Blood Specialty Clinic, Los Alamitos, California, United States
- Ellison Institute of Technology, Los Angeles, California, United States
- Palo Alto Medical Foundation Research Center, Palo Alto, California, United States
- Kaiser Permanente - San Marcos, San Marcos, California, United States
- Palo Alto Medical Foundation Research Center, San Mateo, California, United States
- Palo Alto Medical Foundation Research Center, Sunnyvale, California, United States
- Cancer Specialists of North Florida - Jacksonville, Jacksonville, Florida, United States
- Tallahassee Memorial HealthCare, Tallahassee, Florida, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06790693?
NCT06790693 is a Phase 3 INTERVENTIONAL study titled "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." It is currently recruiting and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 450 participants.
What conditions does NCT06790693 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT06790693?
The interventions being studied include: Inavolisib (DRUG), Placebo (DRUG), CDK4/6i (DRUG), Letrozole (DRUG). Participants will receive oral inavolisib once daily (QD).
What does Phase 3 mean for NCT06790693?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06790693?
This trial is currently "Recruiting." It started on 2025-04-09. The estimated completion date is 2032-05-30.
Who is sponsoring NCT06790693?
NCT06790693 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06790693?
The trial aims to enroll 450 participants. The trial is currently recruiting and accepting new participants.
How is NCT06790693 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06790693?
The primary outcome measures are: Progression-Free Survival (PFS) (From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 7 years)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06790693 being conducted?
This trial is being conducted at 20 sites, including Burbank, California; La Jolla, California; Los Alamitos, California; Los Angeles, California and 16 more sites (United States).
Where can I find official information about NCT06790693?
The official record for NCT06790693 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06790693. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06790693 testing in simple terms?
This trial tests if a new drug, inavolisib, when added to standard treatment (a CDK4/6 inhibitor and letrozole), is better than placebo plus standard treatment for advanced breast cancer. It is for patients with a specific type of advanced breast cancer that is hormone-receptor positive, HER2-negative, and has a PIK3CA mutation.
Why is this trial significant?
This trial addresses a significant unmet need in advanced breast cancer by investigating a novel targeted therapy that aims to improve outcomes for patients with specific genetic mutations. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06790693?
Common side effects may include diarrhea, nausea, vomiting, fatigue, and skin rash. More serious risks can include changes in blood sugar levels, liver problems, and effects on heart function. There is a risk of allergic reactions to the study medications. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06790693?
Ask your doctor about the specific CDK4/6 inhibitor and letrozole you would receive, and how inavolisib or placebo is administered. Be prepared for regular clinic visits for blood tests, scans to check your cancer, and to report any side effects. The study involves taking oral medications daily and potentially for extended periods, depending on disease response. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06790693 signal from an investment perspective?
This trial targets a specific subset of advanced breast cancer, representing a significant market opportunity if successful, with potential for improved efficacy over existing therapies. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves receiving either inavolisib or a placebo along with standard treatment, with regular check-ups and tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.