A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer
New breast cancer treatment tested in early-stage patients
Plain English Summary
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer is a Phase 2 clinical trial sponsored by Hoffmann-La Roche studying Breast Cancer. This trial tests a new combination of drugs, including inavolisib, to treat early-stage breast cancer before surgery. It is for patients with a specific type of breast cancer (ER-positive, HER2-negative) that has a PIK3CA gene mutation. Participants will receive the study drugs and then undergo surgery; they will be closely monitored for side effects. Standard treatment options for this type of breast cancer before surgery include chemotherapy or endocrine therapy alone. The trial aims to enroll 60 participants.
Official Summary
This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you have early-stage (Stage II-III) breast cancer that is ER-positive, HER2-negative, and has a PIK3CA mutation. You must be eligible for surgery after the study treatment. You cannot join if you have Stage IV (metastatic) breast cancer, inflammatory breast cancer, or have already received treatment for your current breast cancer. Individuals with Type 1 diabetes or Type 2 diabetes requiring ongoing treatment are excluded. 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 the percentage of participants who experience side effects, helping researchers understand how safe the new treatment combination is. The specific primary outcome measures are: Percentage of Participants with Adverse Events (AEs) (From first dose up to 30 days after last dose (approximately 8 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 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 aims to find a more effective treatment for a specific subset of early-stage breast cancer patients, addressing a need for targeted therapies that can shrink tumors before surgery. 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 market of early-stage breast cancer patients with PIK3CA mutations, a growing area of precision oncology, suggesting potential for a new targeted therapy if successful Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the specific drugs being tested, potential side effects, and how this treatment compares to standard options. Participation involves receiving study drugs for several months before surgery and regular check-ups to monitor your health and the cancer's response. Be prepared for potential side effects and the need for close medical supervision throughout the study. 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: NONE
- Enrollment: 60 participants
Interventions
- DRUG: Inavolisib — Inavolisib will be administered as per the schedule specified in the arms
- DRUG: Ribociclib — Ribociclib will be administered as per the schedule specified in the arms
- DRUG: Letrozole — Letrozole will be administered as per the schedule specified in the arms
Primary Outcomes
- Percentage of Participants with Adverse Events (AEs) (From first dose up to 30 days after last dose (approximately 8 months))
Secondary Outcomes
- Percentage of Participants with Total Pathological Complete Response (pCR) (Up to approximately 8 months)
- Percentage of Participants with Objective Response Rate (ORR), According to Modified Response Evaluation Criteria in Solid Tumors, Version 1.1 (mRECIST v1.1) (Up to approximately 8 months)
- Change From Baseline in Ki-67 Levels by Immunohistochemistry (IHC) (Baseline, Day 22 of Cycle 1 and at Surgery (up to approximately 8 months). One cycle = 28 days)
- Percentage of Participants Reporting Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire (Up to approximately 8 months)
- Percentage of Participants Reporting Each Response Option at Each Time Point for the Treatment Side-Effect Bother Item (GP5) From the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire (Up to approximately 8 months)
Full Eligibility Criteria
Inclusion Criteria: * Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification * Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy * Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable) * Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines * Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines * Documented Ki-67 score \>=5% as per local assessment * Confirmed PIK3CA mutation Exclusion Criteria: * Stage IV (metastatic) BC * Inflammatory BC (cT4d) * Bilateral invasive BC * History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast * Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, including sentinel lymph node biopsy, radiotherapy, cytotoxic, and endocrine treatments) * Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Trial Locations
- Centro Oncologico Korben, Ciudad Autonoma Buenos Aires, Argentina
- Hospital Araujo Jorge, Goiânia, Goiás, Brazil
- Hospital do Cancer de Pernambuco - HCP, Recife, Pernambuco, Brazil
- Irmandade Da Santa Casa de Misericordia de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda, São Paulo, São Paulo, Brazil
- Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada
- Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal, Quebec, Canada
- Jewish General Hospital, Montreal, Quebec, Canada
- McGill University Health Center, Montreal, Quebec, Canada
- Das Brustzentrum, Berlin, Germany
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT07054190?
NCT07054190 is a Phase 2 INTERVENTIONAL study titled "A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer." It is currently recruiting and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 60 participants.
What conditions does NCT07054190 study?
This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.
What treatments are being tested in NCT07054190?
The interventions being studied include: Inavolisib (DRUG), Ribociclib (DRUG), Letrozole (DRUG). Inavolisib will be administered as per the schedule specified in the arms
What does Phase 2 mean for NCT07054190?
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 NCT07054190?
This trial is currently "Recruiting." It started on 2025-09-09. The estimated completion date is 2027-09-28.
Who is sponsoring NCT07054190?
NCT07054190 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07054190?
The trial aims to enroll 60 participants. The trial is currently recruiting and accepting new participants.
How is NCT07054190 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07054190?
The primary outcome measures are: Percentage of Participants with Adverse Events (AEs) (From first dose up to 30 days after last dose (approximately 8 months)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07054190 being conducted?
This trial is being conducted at 20 sites, including Ciudad Autonoma Buenos Aires; Goiânia, Goiás; Recife, Pernambuco; Porto Alegre, Rio Grande do Sul and 16 more sites (Argentina, Brazil, Canada).
Where can I find official information about NCT07054190?
The official record for NCT07054190 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07054190. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07054190 testing in simple terms?
This trial tests a new combination of drugs, including inavolisib, to treat early-stage breast cancer before surgery. It is for patients with a specific type of breast cancer (ER-positive, HER2-negative) that has a PIK3CA gene mutation.
Why is this trial significant?
This trial aims to find a more effective treatment for a specific subset of early-stage breast cancer patients, addressing a need for targeted therapies that can shrink tumors before surgery.
What are the potential risks of participating in NCT07054190?
Common side effects may include nausea, diarrhea, fatigue, and skin reactions. More serious side effects can occur, such as changes in blood sugar levels or liver problems. The study will closely monitor for and manage any adverse events. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07054190?
Ask your doctor about the specific drugs being tested, potential side effects, and how this treatment compares to standard options. Participation involves receiving study drugs for several months before surgery and regular check-ups to monitor your health and the cancer's response. Be prepared for potential side effects and the need for close medical supervision throughout the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07054190 signal from an investment perspective?
This trial targets a significant market of early-stage breast cancer patients with PIK3CA mutations, a growing area of precision oncology, suggesting potential for a new targeted therapy if successful 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?
Participants will receive the study drugs and then undergo surgery; they will be closely monitored for side effects. 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.
Related Conditions
More Breast Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.