A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation
New Breast Cancer Treatment Trial: Inavolisib Plus Ribociclib and Fulvestrant
Plain English Summary
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer is a Phase 2 clinical trial sponsored by Hoffmann-La Roche studying Breast Cancer. This trial tests a new combination of drugs (inavolisib, ribociclib, and fulvestrant) against a placebo plus ribociclib and fulvestrant. It is for patients with advanced breast cancer that no longer responds to hormone therapy and has specific genetic markers (chromosome 8p loss, no PIK3CA mutation). Participation involves receiving either the new drug combination or a placebo, with regular check-ups and tests. Alternative treatments may include chemotherapy or other targeted therapies, depending on the patient's specific situation and previous treatments. The trial aims to enroll 80 participants.
Official Summary
A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) with chromosome 8p loss (chr8p loss) and without PIK3CA mutation.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with advanced or metastatic breast cancer that is hormone-receptor-positive and HER2-negative. Must not have received prior treatment for advanced or metastatic breast cancer and must have progressed on or after endocrine therapy. Must have specific genetic markers: loss of chromosome 8p and no PIK3CA mutation. Patients with certain conditions like visceral crisis, type 1 diabetes, or active brain metastases are not eligible. 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 measures how many patients experience a confirmed shrinkage or disappearance of their tumors, indicating the new treatment combination is effective in controlling the cancer. The specific primary outcome measures are: Percentage of Participants With Confirmed Objective Response (cORR) (Up to approximately 2 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 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a critical need for new treatments in patients with advanced breast cancer that has become resistant to standard hormone therapies, particularly those with specific genetic altera Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Breast Cancer, where improved treatment options are needed.
Investor Insight
This trial targets a significant unmet need in a large patient population, with potential for a new first-line treatment option if successful, signaling a strong market opportunity for the sponsor. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this trial is right for you, considering your specific cancer type and treatment history. Participation involves regular visits for drug administration, blood tests, scans to monitor your cancer, and to check for side effects. You will be randomly assigned to receive either the new drug combination or a placebo, and neither you nor your doctor will know which you are receiving. This trial is currently recruiting participants. The trial is being conducted at 10 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: QUADRUPLE
- Enrollment: 80 participants
Interventions
- DRUG: Inavolisib — Inavolisib will be administered as per the schedule mentioned in the protocol.
- DRUG: Ribociclib — Ribociclib will be administered as per the schedule mentioned in the protocol.
- DRUG: Fulvestrant — Fulvestrant will be administered as per the schedule mentioned in the protocol.
- DRUG: Placebo — Placebo will be administered as per the schedule mentioned in the protocol.
Primary Outcomes
- Percentage of Participants With Confirmed Objective Response (cORR) (Up to approximately 2 years)
Secondary Outcomes
- Progression-Free Survival (PFS) (Up to approximately 2 years)
- Overall Survival (OS) (Up to approximately 2 years)
- Duration of Response (DOR) (Up to approximately 2 years)
- Percentage of Participants with Clinical Benefit (CBR) (Up to approximately 2 years)
- Percentage of Participants with Adverse Events (AEs) (Up to approximately 2 years)
Full Eligibility Criteria
Inclusion Criteria: * Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent * Documented estrogen receptor (ER)-positive and/or progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines, defined as \>=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020) * Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen * Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss) * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) Exclusion Criteria: * Metaplastic breast cancer * Radiotherapy within 2 weeks before randomization * Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis) * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes * Known and untreated, or active Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible * Any history of leptomeningeal disease or carcinomatous meningitis
Trial Locations
- Hospital Brasilia, Brasília, Federal District, Brazil
- ICTR Curitiba, Curitiba, Paraná, Brazil
- Hospital Santa Rita de Cassia Vitoria, Curitiba, Pará, Brazil
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo, São Paulo, Brazil
- CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital, Chicoutimi, Quebec, Canada
- McGill University, Montreal, Quebec, Canada
- Soon Chun Hyang University Cheonan Hospital, Dongnam-gu, Cheonan-si, South Korea
- Gachon University Gil Medical Center, Namdong-Gu, South Korea
- Seoul National University Bundang Hospital, Seongnam-si, South Korea
- Seoul National University Hospital, Seoul, South Korea
Frequently Asked Questions
What is clinical trial NCT07405801?
NCT07405801 is a Phase 2 INTERVENTIONAL study titled "A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer." It is currently recruiting and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 80 participants.
What conditions does NCT07405801 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT07405801?
The interventions being studied include: Inavolisib (DRUG), Ribociclib (DRUG), Fulvestrant (DRUG), Placebo (DRUG). Inavolisib will be administered as per the schedule mentioned in the protocol.
What does Phase 2 mean for NCT07405801?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07405801?
This trial is currently "Recruiting." It started on 2026-04-30. The estimated completion date is 2030-02-26.
Who is sponsoring NCT07405801?
NCT07405801 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07405801?
The trial aims to enroll 80 participants. The trial is currently recruiting and accepting new participants.
How is NCT07405801 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple 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 NCT07405801?
The primary outcome measures are: Percentage of Participants With Confirmed Objective Response (cORR) (Up to approximately 2 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07405801 being conducted?
This trial is being conducted at 10 sites, including Brasília, Federal District; Curitiba, Paraná; Curitiba, Pará; São Paulo, São Paulo and 6 more sites (Brazil, Canada, South Korea).
Where can I find official information about NCT07405801?
The official record for NCT07405801 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07405801. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07405801 testing in simple terms?
This trial tests a new combination of drugs (inavolisib, ribociclib, and fulvestrant) against a placebo plus ribociclib and fulvestrant. It is for patients with advanced breast cancer that no longer responds to hormone therapy and has specific genetic markers (chromosome 8p loss, no PIK3CA mutation).
Why is this trial significant?
This trial addresses a critical need for new treatments in patients with advanced breast cancer that has become resistant to standard hormone therapies, particularly those with specific genetic altera
What are the potential risks of participating in NCT07405801?
Common side effects may include fatigue, nausea, diarrhea, and changes in blood counts. More serious side effects can occur, and patients will be closely monitored for any adverse events. The study drugs may interact with other medications, so it's important to tell your doctor about all medicines you are taking. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07405801?
Ask your doctor if this trial is right for you, considering your specific cancer type and treatment history. Participation involves regular visits for drug administration, blood tests, scans to monitor your cancer, and to check for side effects. You will be randomly assigned to receive either the new drug combination or a placebo, and neither you nor your doctor will know which you are receiving. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07405801 signal from an investment perspective?
This trial targets a significant unmet need in a large patient population, with potential for a new first-line treatment option if successful, signaling a strong market opportunity for the sponsor. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participation involves receiving either the new drug combination or a placebo, 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.