A Prospective Non-interventional Study to Evaluate the Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (reaINAVO)
Study evaluating inavolisib for advanced breast cancer in China
Plain English Summary
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer is a Not Applicable clinical trial sponsored by Hoffmann-La Roche studying Locally Advanced Breast Cancer, Metastatic Breast Cancer. This observational study tests how well inavolisib works and how safe it is for patients with a specific type of advanced or metastatic breast cancer. It is for patients in China with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who have finished initial endocrine therapy. Participation involves receiving inavolisib, potentially with other standard treatments, as prescribed by a doctor in routine clinical practice. Alternatives may include other cancer therapies or palliative care, depending on the patient's specific situation and doctor's recommendation. The trial aims to enroll 500 participants.
Official Summary
The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients diagnosed with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer. Patients must have experienced cancer recurrence after completing adjuvant endocrine therapy. Patients must be receiving inavolisib for the first time. Patients must have a PIK3CA mutation confirmed by an approved test (blood or tumor tissue) before starting inavolisib. This trial is studying Locally Advanced Breast Cancer, 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 (progression-free survival) while receiving inavolisib, indicating how effective the treatment is in controlling The specific primary outcome measures are: Real-world Progression-free Survival (rwPFS) (From index date (date of first prescription of inavolisib) to first occurrence of disease progression (PD)/death from any cause (up to approximately 36 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 study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a need for effective treatments in patients with specific genetic mutations (PIK3CA) in advanced breast cancer that no longer responds to standard endocrine therapy. This research targets Locally Advanced Breast Cancer, Metastatic Breast Cancer, where improved treatment options are needed.
Investor Insight
This study signals potential for inavolisib in a niche but significant breast cancer market, with a focus on PIK3CA-mutated tumors, suggesting a targeted therapy approach with potential for future app
Is This Trial Right for Me?
Ask your doctor if your cancer has the PIK3CA mutation and if inavolisib is a suitable treatment option for you. Understand that this is an observational study, meaning you will receive treatment as part of your regular medical care, and your progress will be tracked. Be prepared for regular doctor visits and potential side effects, and discuss any concerns openly with your healthcare team. This trial is currently recruiting participants. The trial is being conducted at 9 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: OBSERVATIONAL
- Enrollment: 500 participants
Interventions
- DRUG: Inavolisib — Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
- DRUG: Palbociclib — Palbociclib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
- DRUG: Fulvestrant — Fulvestrant will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
Primary Outcomes
- Real-world Progression-free Survival (rwPFS) (From index date (date of first prescription of inavolisib) to first occurrence of disease progression (PD)/death from any cause (up to approximately 36 months))
Secondary Outcomes
- Number of Participants With Adverse Events (AEs) (Up to approximately 36 months)
- Real-world Time to Progression (rwTTP) (From index date to first occurrence of PD (up to approximately 36 months))
- Number of Participants With Real-world Tumor Response (rwTR) to the Treatment (Up to approximately 36 months)
- Real-world Duration of Response (rwDoR) (From onset of first tumor response to first occurrence of PD or death from any cause (up to approximately 36 months))
- Real-world Time-to-treatment Discontinuation (rwTTD) (From index date to inavolisib discontinuation, new anti-cancer therapy initiation or death from any cause (up to approximately 36 months))
Full Eligibility Criteria
Inclusion Criteria: * Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+/HER2- LA/mBC, following recurrence on or after completing adjuvant endocrine therapy * Participants must receive the treatment of inavolisib for the first time * PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay \[Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)\] by testing of blood or tumor tissue prior to the initiation of inavolisib Exclusion Criteria: * Participants for which the treatment with inavolisib is not indicated per prescribing information. If the participant starts palbociclib and fulvestrant first, and starts inavolisib after getting a PIK3CA mutation-positive test result later, the palbociclib and fulvestrant will not be deemed as a different line of therapy. However, the medical order of PIK3CA mutation test must be made before or at the same time with the prescription of palbociclib and fulvestrant * Participants not receiving treatment for LA/mBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)/local labeling * At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study
Trial Locations
- Wenzhou Medical University Affiliated Second Hospital, Wenzhou, Zhejiang, China
- Peking University First Hospital, Beijing, China
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital, Chengdu, China
- Zhujiang Hospital, Southern Medical University, Guangzhou, China
- Jiangxi Cancer Hospital, Nanchang, China
- Jiangsu Province Hospital, Nanjing, China
- Fudan University Shanghai Cancer Center, Shanghai, China
- Hubei Cancer Hospital, Wuhan, China
- Subei People's Hospital of Jiangsu province, Yangzhou, China
Frequently Asked Questions
What is clinical trial NCT07347600?
NCT07347600 is a Not Applicable OBSERVATIONAL study titled "A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer." It is currently recruiting and is sponsored by Hoffmann-La Roche. The trial targets enrollment of 500 participants.
What conditions does NCT07347600 study?
This trial investigates treatments for Locally Advanced Breast Cancer, Metastatic Breast Cancer. The primary condition under study is Locally Advanced Breast Cancer.
What treatments are being tested in NCT07347600?
The interventions being studied include: Inavolisib (DRUG), Palbociclib (DRUG), Fulvestrant (DRUG). Inavolisib will be administered at the discretion of the physician in accordance with local clinical practice and local labeling.
What does Not Applicable mean for NCT07347600?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07347600?
This trial is currently "Recruiting." It started on 2026-01-21. The estimated completion date is 2029-09-09.
Who is sponsoring NCT07347600?
NCT07347600 is sponsored by Hoffmann-La Roche. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07347600?
The trial aims to enroll 500 participants. The trial is currently recruiting and accepting new participants.
How is NCT07347600 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07347600?
The primary outcome measures are: Real-world Progression-free Survival (rwPFS) (From index date (date of first prescription of inavolisib) to first occurrence of disease progression (PD)/death from any cause (up to approximately 36 months)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07347600 being conducted?
This trial is being conducted at 9 sites, including Wenzhou, Zhejiang; Beijing; Chengdu; Guangzhou and 5 more sites (China).
Where can I find official information about NCT07347600?
The official record for NCT07347600 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07347600. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07347600 testing in simple terms?
This observational study tests how well inavolisib works and how safe it is for patients with a specific type of advanced or metastatic breast cancer. It is for patients in China with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer who have finished initial endocrine therapy.
Why is this trial significant?
This trial addresses a need for effective treatments in patients with specific genetic mutations (PIK3CA) in advanced breast cancer that no longer responds to standard endocrine therapy.
What are the potential risks of participating in NCT07347600?
Common side effects may include diarrhea, nausea, vomiting, and fatigue. Serious side effects can occur, including severe skin reactions, high blood sugar, and electrolyte imbalances. It is important to report any new or worsening symptoms to your doctor immediately. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07347600?
Ask your doctor if your cancer has the PIK3CA mutation and if inavolisib is a suitable treatment option for you. Understand that this is an observational study, meaning you will receive treatment as part of your regular medical care, and your progress will be tracked. Be prepared for regular doctor visits and potential side effects, and discuss any concerns openly with your healthcare team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07347600 signal from an investment perspective?
This study signals potential for inavolisib in a niche but significant breast cancer market, with a focus on PIK3CA-mutated tumors, suggesting a targeted therapy approach with potential for future app This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves receiving inavolisib, potentially with other standard treatments, as prescribed by a doctor in routine clinical practice. 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
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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.