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 (NCT02437318) enrolled 572 people in total — 284 received alpelisib combined with fulvestrant, and 288 received a placebo combined with fulvestrant. Participants were divided into groups based on whether their tumour carried a specific gene change called a PIK3CA mutation (detected through tumour tissue testing). The trial was primarily measuring how long people in the PIK3CA-mutant group went without their cancer growing or spreading — a measure called "progression-free survival." The reported data shows that, among participants whose tumour tissue tested positive for the PIK3CA mutation, the median time before disease progression or death was 11.0 months in the alpelisib + fulvestrant group, compared with 5.7 months in the placebo + fulvestrant group. Median overall survival (the midpoint for how long people lived from the start of the trial) was reported as 39.3 months versus 31.4 months in these same two groups. In the group whose tumours did not carry the PIK3CA mutation, the reported median progression-free survival figures were very close — 7.43 months for alpelisib + fulvestrant and 7.23 months for placebo + fulvestrant — and overall survival was 37.29 months versus 34.30 months respectively. The reported data also shows several secondary measurements. The proportion of participants whose tumours shrank (called the overall response rate) was 26.6% in the PIK3CA-mutant alpelisib group versus 13.4% in the placebo group; in the non-mutant group it was 20.9% versus 12.9%. A broader measure — the "clinical benefit rate," which counted people whose disease shrank or stayed stable for more than 24 weeks — was 61.5% versus 44.8% in the PIK3CA-mutant groups, and 53.9% versus 49.1% in the non-mutant groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
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, Completed
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
- If you are female, you must be postmenopausal.
- Your cancer must have been tested to determine the status of a gene called PIK3CA.
- You relapsed (cancer came back) with clear evidence it was growing while on, or within 12 months of finishing, hormone therapy given before/after surgery, and you have not yet had treatment for cancer that has spread.
- You relapsed more than 12 months after finishing hormone therapy given before/after surgery, and then your cancer grew again during or after one hormone therapy treatment for cancer that had spread.
- You were newly diagnosed with advanced breast cancer and your cancer grew during or after one hormone therapy treatment.
- Your cancer got worse during or after treatment with a type of hormone therapy called an aromatase inhibitor (such as letrozole, anastrozole, or exemestane).
- Your breast cancer has been confirmed by a lab test to be estrogen-receptor positive and HER2 negative.
- Your cancer can be measured on scans, or you have at least one bone lesion of a specific type (confirm with trial site).
- Your blood counts and bone marrow are working well enough (confirm with trial site).
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.
- Your cancer has spread to organs in a way that is causing symptoms, or your overall disease burden makes hormone therapy unsuitable, as judged by the doctor.
- You have previously been treated with chemotherapy (other than chemotherapy given before or after surgery), the drug fulvestrant, or certain targeted drugs that affect the PI3K, mTOR, or AKT pathways.
- You have a type of breast cancer called inflammatory breast cancer.
- You have moderate or severe liver problems (known as Child-Pugh score B or C).
- You have Type 1 diabetes, or Type 2 diabetes that is not well controlled.
- Your general health and ability to carry out daily activities is significantly limited (confirm with trial site).
- Your cancer has spread to the brain or spinal cord, unless it has been stable for at least 4 weeks, you are not on steroids, and you are not taking certain anti-seizure medications.
- You have taken part in another clinical trial within 30 days before joining, or within a certain timeframe based on the previous trial drug (confirm with trial site).
- You have had a severe episode of pancreatitis (inflammation of the pancreas) within the past year, or have a history of long-term pancreatitis.
- You relapsed more than 12 months after finishing hormone therapy given before/after surgery but have not had any treatment for cancer that has spread.
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.
Trial contact details on record
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Australian sites
This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.
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 4 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) Per Investigator Assessment in the PIK3CA Mutant Cohort
Other options
Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.