A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
New breast cancer treatment study for advanced, HER2-positive, PIK3CA-mutated disease
Plain English Summary
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer is a Phase 3 clinical trial sponsored by Hoffmann-La Roche studying Metastatic Breast Cancer. This study tests if a new drug, inavolisib, combined with Phesgo, is better than Phesgo alone for advanced HER2-positive breast cancer with a specific gene mutation (PIK3CA). It is for patients with HER2-positive, PIK3CA-mutated, locally advanced or metastatic breast cancer who have not received prior treatment for advanced disease. Participants will receive either inavolisib plus Phesgo or a placebo plus Phesgo after initial chemotherapy, and will have regular check-ups and tests. Alternative treatments include standard chemotherapy, targeted therapies, and endocrine therapy, depending on the patient's specific situation and prior treatments. The trial aims to enroll 230 participants.
Official Summary
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with HER2-positive, PIK3CA-mutated, locally advanced or metastatic breast cancer. Must have a good general health status (ECOG 0 or 1) and adequate organ function. Cannot have received prior treatment for advanced or metastatic HER2-positive breast cancer, or specific PI3K pathway inhibitors. Age is not specified, but patients must have a normal heart function (LVEF >= 50%). This trial is studying Metastatic Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how long patients live without their cancer getting worse, which indicates how well the new drug combination controls the disease. The specific primary outcome measures are: Investigator-Assessed Progression-Free Survival (PFS) (Up to approximately 40 months). 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 need for more effective maintenance therapies in a specific subtype of advanced breast cancer, aiming to improve outcomes for patients with PIK3CA-mutated HER2-positive disease. 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 Metastatic Breast Cancer, where improved treatment options are needed.
Investor Insight
This Phase III trial for a targeted therapy in a specific breast cancer subtype signals a significant market opportunity for advanced breast cancer treatments, with potential for improved efficacy ove 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 if your cancer is HER2-positive and has a PIK3CA mutation, and if this trial is a good fit for you. Participation involves receiving study medication (inavolisib or placebo) along with Phesgo, and attending regular clinic visits for monitoring and tests. You will undergo initial chemotherapy followed by maintenance therapy with the study drugs for up to approximately 40 months, or until your cancer progresses. 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: 230 participants
Interventions
- DRUG: Inavolisib — Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.
- DRUG: Phesgo — Phesgo will be administered to participants subcutaneously every 3 weeks (Q3W) on D1 of each 21-day cycle.
- DRUG: Placebo — Inavolisib-matching tablet taken PO QD on Days 1-21 of each 21-day cycle, beginning on D1 C1 of maintenance treatment.
- DRUG: Taxane-based Chemotherapy — During the induction therapy phase, the investigator's choice of taxane-based chemotherapy will be administered after Phesgo.
- DRUG: Optional Endocrine Therapy of Investigator's Choice — Optional endocrine therapy (ET) is allowed at the discretion of the investigator, based on the standard of care. Allowed ETs are tamoxifen, or one of the specified third-generation aromatase inhibitor (AI \[anastrozole, letrozole, or exemestane\]), or fulvestrant. The investigator will determine and supply the appropriate luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information
Primary Outcomes
- Investigator-Assessed Progression-Free Survival (PFS) (Up to approximately 40 months)
Secondary Outcomes
- Overall Survival (OS) (Up to approximately 111 months)
- Investigator-Assessed Objective Response Rate (ORR) (Up to approximately 111 months)
- Investigator-Assessed Duration of Response (DOR) (Up to approximately 111 months)
- Investigator-Assessed Clinical Benefit Rate (CBR) (Up to approximately 111 months)
- Investigator-Assessed PFS2 (Up to approximately 111 months)
Full Eligibility Criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection * Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity * Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status * Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \>= 6 months * LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) * Adequate hematologic and organ function prior to initiation of study treatment Exclusion Criteria: * Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway * Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy * History or active inflammatory bowel disease * Disease progression within 6 months of receiving any HER2-targeted therapy * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Participants with active HBV infection * Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis * Symptomatic active lung disease, including pneumonitis or interstitial lung disease * Any history of leptomeningeal disease or carcinomatous meningitis * Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1 * Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition * Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
Trial Locations
- Banner Health MD Anderson AZ, Gilbert, Arizona, United States
- Disney Family Cancer Center, Burbank, California, United States
- City of Hope, Corona, California, United States
- City of Hope Comprehensive Cancer Center, Duarte, California, United States
- City of Hope at Irvine Lennar, Irvine, California, United States
- Ellison Institute of Technology, Los Angeles, California, United States
- Georgetown Uni Hospital, Washington D.C., District of Columbia, United States
- Medstar Research Institute, Hyattsville, Maryland, United States
- Dana Farber Cancer Institute, Boston, Massachusetts, United States
- Henry Ford Hospital, Detroit, Michigan, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT05894239?
NCT05894239 is a Phase 3 INTERVENTIONAL study titled "A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer." It is currently recruiting and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 230 participants.
What conditions does NCT05894239 study?
This trial investigates treatments for Metastatic Breast Cancer. The primary condition under study is Metastatic Breast Cancer.
What treatments are being tested in NCT05894239?
The interventions being studied include: Inavolisib (DRUG), Phesgo (DRUG), Placebo (DRUG), Taxane-based Chemotherapy (DRUG), Optional Endocrine Therapy of Investigator's Choice (DRUG). Participants will receive an inavolisib tablet to be taken orally (PO), once a day (QD), on Days 1-21 of each 21-day cycle, beginning on Day (D) 1 of Cycle (C) 1 of maintenance treatment.
What does Phase 3 mean for NCT05894239?
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 NCT05894239?
This trial is currently "Recruiting." It started on 2023-09-08. The estimated completion date is 2032-12-28.
Who is sponsoring NCT05894239?
NCT05894239 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05894239?
The trial aims to enroll 230 participants. The trial is currently recruiting and accepting new participants.
How is NCT05894239 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 NCT05894239?
The primary outcome measures are: Investigator-Assessed Progression-Free Survival (PFS) (Up to approximately 40 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05894239 being conducted?
This trial is being conducted at 20 sites, including Gilbert, Arizona; Burbank, California; Corona, California; Duarte, California and 16 more sites (United States).
Where can I find official information about NCT05894239?
The official record for NCT05894239 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05894239. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05894239 testing in simple terms?
This study tests if a new drug, inavolisib, combined with Phesgo, is better than Phesgo alone for advanced HER2-positive breast cancer with a specific gene mutation (PIK3CA). It is for patients with HER2-positive, PIK3CA-mutated, locally advanced or metastatic breast cancer who have not received prior treatment for advanced disease.
Why is this trial significant?
This trial addresses a need for more effective maintenance therapies in a specific subtype of advanced breast cancer, aiming to improve outcomes for patients with PIK3CA-mutated HER2-positive disease. 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 NCT05894239?
Common side effects may include diarrhea, nausea, fatigue, and skin rash. Potential serious side effects include high blood sugar, heart problems, and severe allergic reactions. The study involves regular monitoring for side effects, and participants should report any new or worsening symptoms to their doctor immediately. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05894239?
Ask your doctor if your cancer is HER2-positive and has a PIK3CA mutation, and if this trial is a good fit for you. Participation involves receiving study medication (inavolisib or placebo) along with Phesgo, and attending regular clinic visits for monitoring and tests. You will undergo initial chemotherapy followed by maintenance therapy with the study drugs for up to approximately 40 months, or until your cancer progresses. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05894239 signal from an investment perspective?
This Phase III trial for a targeted therapy in a specific breast cancer subtype signals a significant market opportunity for advanced breast cancer treatments, with potential for improved efficacy ove 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?
Participants will receive either inavolisib plus Phesgo or a placebo plus Phesgo after initial chemotherapy, and will have 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.