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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01958021

NCT01958021
Completed Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are a woman with advanced breast cancer (either spread to other parts of the body, or returned in the local area) that cannot be cured.
  • You have gone through menopause — either naturally (based on age or periods stopping for 12+ months), or because you had both ovaries surgically removed.
  • You have not yet received any systemic (whole-body) treatment, such as chemotherapy or hormone therapy, for your advanced breast cancer.
  • Your breast cancer has been confirmed by a lab test to be estrogen-receptor positive and/or progesterone-receptor positive.
  • Your breast cancer has been confirmed by a lab test to be HER2-negative.
  • You have at least one area of cancer that can be measured on a scan, or at least one bone lesion of a specific type (confirm with trial site).
  • Your general health and ability to carry out daily activities is rated at a good level (ECOG score of 0 or 1 — confirm with trial site).

Who may not be able to join:

  • You have previously taken a CDK4/6 inhibitor medication (confirm with trial site for examples).
  • You have already received systemic treatment (such as chemotherapy or hormone therapy) for your advanced breast cancer — though short-term use of certain hormone therapies (14 days or less) may be allowed (confirm with trial site).
  • You are currently taking another anti-cancer treatment at the same time.
  • You have had another cancer within the past 3 years, with some exceptions such as certain treated skin cancers or cervical cancer that was fully removed.
  • You have active heart problems or a significant history of heart issues, including heart attacks, heart failure, irregular heartbeats, cardiomyopathy, low heart pumping function, or abnormal heart readings on a screening test.
  • Your blood pressure at screening is too high (above 160) or too low (below 90) (confirm with trial site for units).
  • You are currently taking certain medications that cannot be stopped at least 7 days before starting the trial, including some that affect how the body processes drugs, affect heart rhythm, or include herbal supplements (confirm with trial site for specific 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.

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
Completed
Phase
Phase 3
Sponsor
Novartis Pharmaceuticals
Registry
clinicaltrials_gov
Start date
17 December 2013
Est. completion
29 January 2016

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇱🇧 Lebanon 🇳🇱 Netherlands 🇳🇴 Norway 🇷🇺 Russia 🇸🇬 Singapore 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Progression Free Survival (PFS) by Investigator Assessment

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