Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04191499) enrolled 325 people in total — 161 in one group and 164 in the other. Participants were randomly assigned to receive either a combination of three medicines (inavolisib, palbociclib, and fulvestrant, referred to here as Inavo+Palbo+Fulv) or a similar combination where inavolisib was replaced by a placebo — an inactive dummy treatment (Pbo+Palbo+Fulv). The trial's main goal was to measure "progression-free survival" (PFS), which is the length of time from when a participant joined the trial until their cancer showed signs of growing or spreading, or until they died — whichever came first. The reported data shows that none of the 325 participants had formally "completed" the study by the time results were submitted, meaning the trial was still ongoing or had ended early for all participants. The reported data shows that the median PFS — meaning the point in time by which half the participants in each group had experienced disease progression or death — was 15 months in the Inavo+Palbo+Fulv group and 7.3 months in the Pbo+Palbo+Fulv group. These figures were calculated using a standard statistical method called Kaplan-Meier, which estimates timelines when not all participants have been followed for the same length of time. For all of the secondary outcomes — including the percentage of participants whose cancer shrank (objective response rate), how long those responses lasted (duration of response), overall clinical benefit, and overall survival (total length of life) — the results data was not reported on ClinicalTrials.gov at the time of this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Breast Cancer Trial, Active, Not Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- You have been diagnosed with breast cancer that is hormone receptor-positive (HR+) and HER2-negative
- Your cancer has spread to other parts of the body or is advanced in a way that cannot be cured with current treatments
- Your cancer got worse while you were taking hormone-blocking therapy (such as an aromatase inhibitor or tamoxifen), or it came back within 12 months of finishing that therapy
- If you have not yet gone through menopause, you have been receiving a specific hormone-suppressing injection (LHRH agonist) for at least 2 weeks before starting the trial
- Your tumor has tested positive for a specific gene change (PIK3CA mutation) using an approved test
- You are willing to provide a tumor tissue sample (either a recent biopsy or a stored sample)
- Your cancer can be measured on scans according to standard criteria (RECIST v1.1); cancer that has only spread to bones without a measurable soft-tissue component does not qualify (confirm with trial site)
- You are able to carry out normal daily activities with little or no limitation (confirm with trial site)
- You are expected to live for more than 6 months
- Your blood counts and organ function (such as liver and kidneys) are at acceptable levels within 14 days before starting treatment
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- You have a specific rare type of breast cancer called metaplastic breast cancer
- You have ever had cancer spread to the membranes surrounding your brain or spinal cord
- You have previously received any systemic (whole-body) treatment for breast cancer that has spread
- You have previously been treated with fulvestrant or a similar drug, unless it was given before surgery for no longer than 6 months
- You have previously been treated with drugs that target a specific cell-signalling pathway called PI3K, AKT, or mTOR
- You have Type 1 diabetes at any point in your history, or you currently need ongoing medication to manage Type 2 diabetes
- You have brain metastases (cancer spread to the brain) that are known but have not been treated, or are currently active; people with previously treated brain metastases may still be eligible (confirm with trial site)
- You have an active eye infection or inflammation, or you are expected to need eye surgery during the trial
- You have active lung disease causing symptoms, or you need to use supplemental oxygen every day
- You have a history of inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or currently have active bowel inflammation
- You have received any cancer treatment within 2 weeks before joining the trial
- You have taken part in another clinical trial involving an experimental drug within 4 weeks before joining
- You have previously had radiation therapy covering 25% or more of your bone marrow, or you have had a stem cell or bone marrow transplant
- You are currently taking long-term steroid medications or drugs that suppress the immune system
- You are pregnant, breastfeeding, or planning to become pregnant during the trial or within 2 weeks after your last dose of study treatment
- You have had a major operation or a serious physical injury within 28 days before starting the trial
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, including 5 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Progression-Free Survival (PFS)
Other options
Data last synced from ClinicalTrials.gov: 1 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.