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

NCT00777101

NCT00777101
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with advanced or late-stage breast cancer (Stage IIIB, IIIC, or IV) that tests positive for a protein called HER2 (also written as erbB2)
  • You have previously been treated with a drug called Herceptin (trastuzumab) and a type of chemotherapy called a taxane
  • Your heart and kidneys are working well enough to take part (confirm with trial site)

Who may not be able to join:

  • You have been treated with Herceptin (trastuzumab) as part of more than 2 different treatment plans, or you have previously taken Xeloda (capecitabine) and/or Tykerb (lapatinib)
  • Your bones are the only part of your body where the cancer has spread
  • Your cancer has spread to the brain or spinal cord and is currently active — those whose brain/spinal cord disease is stable and who are no longer taking anti-seizure medications or steroids may still be considered (confirm with trial site)
  • You have a significant digestive or stomach condition where diarrhoea is a major problem

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 2: approximately ~30% 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 2
Sponsor
Puma Biotechnology, Inc.
Registry
clinicaltrials_gov
Start date
4 February 2009
Est. completion
1 March 2011

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇭🇷 Croatia 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇯🇴 Jordan 🇲🇽 Mexico 🇵🇱 Poland Puerto Rico 🇷🇴 Romania 🇷🇺 Russia 🇷🇸 Serbia 🇸🇬 Singapore 🇸🇮 Slovenia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇨🇭 Switzerland 🇹🇼 Taiwan 🇹🇭 Thailand 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Progression Free Survival

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