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NCT02246621

NCT02246621
Active, Not Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • 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:

  • 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.

Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 3
Sponsor
Eli Lilly and Company
Registry
clinicaltrials_gov
Start date
6 November 2014
Est. completion
31 January 2017

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇳🇱 Netherlands 🇳🇿 New Zealand 🇷🇺 Russia 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

8 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Progression Free Survival (PFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

View original record on ClinicalTrials.gov