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 (NCT02675231) enrolled 237 people in total, with 79 participants assigned to each of three treatment groups. The groups were: (1) abemaciclib combined with trastuzumab and fulvestrant, (2) abemaciclib combined with trastuzumab only, and (3) trastuzumab combined with standard chemotherapy. The trial's main focus was measuring how long participants went without their cancer visibly growing or spreading — known as "progression-free survival" — and several secondary measures including how many participants were still alive at one, two, and three years, how many showed a measurable reduction in tumour size, and how long those reductions lasted. The reported data shows that for the primary measure of time without disease progression, the abemaciclib-plus-trastuzumab-plus-fulvestrant group had a median of 8.3 months, while both the abemaciclib-plus-trastuzumab group and the chemotherapy comparison group each had a median of 5.7 months. ("Median" here means the midpoint — half of participants in each group reached that time point before progression, and half had not yet.) For overall survival, the reported data shows that at one year, approximately 77% of participants in each abemaciclib group and approximately 70% in the chemotherapy group were still alive. At two years, those figures were around 56%, 56%, and 43% respectively, and at three years approximately 47%, 40%, and 30%. Regarding tumour shrinkage, about 33% of participants in the abemaciclib-plus-trastuzumab-plus-fulvestrant group showed a measurable reduction, compared with about 14% in each of the other two groups. Among those who did show a reduction, the reported duration of that response was a median of 12.5 months in the first group and 9.5 months in the second group; this figure was not reported for the chemotherapy group. 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 2 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
- You have been diagnosed with breast cancer that is both HR+ (hormone receptor-positive) and HER2+ (HER2-positive).
- Your breast cancer cannot be removed by surgery, has come back locally, or has spread to other parts of the body (metastatic).
- You have enough tumor tissue available for testing before joining the trial.
- Your cancer can be measured or tracked using standard imaging methods.
- You have previously received at least 2 treatments specifically targeting HER2 for advanced disease.
- You have previously received a specific drug called trastuzumab emtansine (T-DM1) at some point during your treatment.
- You have previously received a type of chemotherapy called a taxane at some point during your treatment.
- You may have received hormone therapy before, but not fulvestrant.
- You are postmenopausal — either naturally, through surgery, or through medication that suppresses your ovaries.
- Your general health and ability to carry out daily activities falls within an acceptable range (confirm with trial site).
- Your heart is pumping blood effectively enough, with a specific heart function score of 50% or higher.
- Your liver, kidneys, and other organs are functioning well enough to participate.
- If your menopause was brought on by certain medications or radiation, you have had a negative pregnancy test within 14 days before joining and agree to use approved contraception during the study and for 12 weeks after your last dose.
- If you had recent localized radiation therapy, it was completed at least 2 weeks before joining and you have recovered from its side effects.
- You have stopped all previous cancer treatments for the required amount of time before starting the study drug (at least 21 days for certain types, or 14 days for others), and have recovered from their side effects — except for trastuzumab, which may continue.
- 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, life-threatening crisis affecting your internal organs (confirm with trial site).
- You have cancer that has spread to your brain or spinal cord and is untreated, causing symptoms, or requires steroids to manage.
- You had major surgery within the 14 days before joining the trial.
- You have previously been treated with a type of drug called a CDK 4/6 inhibitor.
- You have recently received an experimental drug that has not been officially approved, within 14–21 days before joining.
- You have a serious pre-existing health condition that the study doctor believes would make it unsafe for you to participate.
- You have had heart failure with symptoms, a heart attack, or unstable chest pain within the past 6 months.
- You have had certain serious heart rhythm problems or a sudden cardiac arrest within the past 12 months.
- You have a history of another cancer in the past 3 years (skin cancers of certain types or very early-stage cervical changes may be exceptions — confirm with trial site).
- You currently have an active bacterial, fungal, or detectable viral infection.
- You have received a live virus vaccine within the 28 days before joining the trial.
- You have a known allergy or sensitivity to trastuzumab, fulvestrant, or certain related substances used in these medications.
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 3 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.