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 (NCT02246621) enrolled 493 people in total — 328 in the group receiving abemaciclib combined with a type of hormone-blocking drug called a nonsteroidal aromatase inhibitor (NSAI), and 165 in the group receiving a placebo (inactive dummy treatment) combined with the same NSAI. The trial was primarily measuring how long participants went without their disease getting worse (called "progression-free survival"), and also looked at a number of secondary measures including how many participants' tumours shrank or disappeared, how long those responses lasted, and how many participants had their disease kept under control. The reported data shows that, for the primary measure, the abemaciclib + NSAI group went a reported median (the middle value in the group) of 28.18 months before their disease progressed or they died, compared with 14.76 months in the placebo + NSAI group. For the secondary measures, the reported data shows that 49.7% of participants in the abemaciclib group had their tumour shrink significantly or disappear entirely, compared with 37% in the placebo group. Among those who did respond in this way, the response lasted a reported median of 27.39 months in the abemaciclib group versus 17.46 months in the placebo group. Disease control (meaning the tumour shrank, disappeared, or stayed stable) was reported in 88.7% of the abemaciclib group and 86.7% of the placebo group. A longer-term benefit measure — stable or shrinking disease lasting at least 6 months — was reported in 78.0% of the abemaciclib group and 71.5% of the placebo group. Overall survival data was listed as a secondary outcome but no figures were reported in the submitted results. 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 a type of breast cancer that is hormone receptor-positive (HR+) and HER2-negative (HER2-)
- Your breast cancer has either come back in the local area and cannot be fully removed by surgery or treated with curative radiation, or it has spread to other parts of the body (metastatic)
- You have gone through menopause
- Your cancer can be measured on scans, or you have cancer that has spread only to the bones (even if it cannot be easily measured)
- You are generally able to carry out daily activities with little to no limitation, based on a standard health scale used in cancer trials (confirm with trial site)
- Your liver, kidneys, and other organs are working well enough to safely take part in the trial
- If you have had localized radiation therapy recently (for pain relief or bone protection), you have finished it before joining and have recovered from any side effects
- You are able to swallow capsules
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 is causing a serious crisis in your internal organs, has spread through the lymph vessels of the lungs, or has spread to the lining around the brain and spinal cord
- You have a type of breast cancer called inflammatory breast cancer
- There is any sign or history of cancer spreading to the brain or central nervous system
- You are currently receiving or have previously received hormone-based (endocrine) therapy for breast cancer that has come back or spread
- You received hormone-based therapy before or after surgery, and your cancer came back within 12 months of finishing that treatment
- You are currently receiving or have previously received chemotherapy for breast cancer that has come back or spread
- You have previously been treated with a drug called everolimus
- You have previously been treated with a type of drug called a CDK 4/6 inhibitor, or you are in another trial for this type of drug where you do not yet know what treatment you received
- You started taking bone-strengthening medications (bisphosphonates or RANK-L inhibitors) fewer than 7 days before joining the trial
- You are currently taking part in another clinical trial or medical research study that may interfere with this one
- You have recently received an experimental drug that has not yet been approved — within the last 14 or 21 days, depending on the type of drug (confirm with trial site)
- You have had major surgery within the 14 days before joining 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 8 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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.