NCT02019277
Who may be able to join
Who might be able to join this trial:
- Your breast cancer tumor tests positive for a protein called HER2 (confirmed by lab testing of the tumor).
- You have been diagnosed with breast cancer that has spread to other parts of the body (metastatic), confirmed by a tissue or cell sample, with at least one area that can be measured or tracked.
- You are well enough to carry out daily activities at a certain level (your doctor will assess this using a standard scale, and the required level depends on which chemotherapy you would receive).
- Your heart is pumping well enough, confirmed by a heart scan (ECHO or MUGA), showing at least 50% function before starting treatment.
- You have previously had HER2-targeted therapy before your cancer spread (before or after surgery) — this is allowed.
- You may be able to take hormone therapy alongside this trial, following your hospital's guidelines, but not at the same time as the chemotherapy used in this trial.
Who may not be able to join:
- You have already received non-hormonal treatments (such as chemotherapy) aimed at your metastatic breast cancer.
- You have a history of other cancers, unless it was an early-stage cervical or skin cancer that was fully treated, another cancer you have been free of for at least 5 years, or an early form of breast cancer (DCIS) that was fully treated.
- You are pregnant, breastfeeding, or have a positive pregnancy test within 7 days before starting treatment (confirm with trial site).
- You have severe nerve damage in your hands or feet (a condition called peripheral neuropathy at grade 3 or higher).
- Scans show your cancer has spread to the brain or spinal cord, unless it has been treated, has been stable for at least 3 months, and you no longer need steroid medication for it.
- You have other serious illnesses that could interfere with treatment, including serious lung conditions.
- Your kidneys, liver, or other organs are not working well enough (confirm specific requirements with trial site).
- You have serious heart problems that would make one of the trial drugs (trastuzumab) unsafe for you.
- You have severe difficulty breathing while at rest, or you need extra oxygen to breathe.
- You are currently taking part in another clinical trial using an experimental cancer treatment, or have done so within 28 days before starting this 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.
Trial details
Where this trial is recruiting
13 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percentage of Participants With Adverse Events (AEs) and Serious AEs; Percentage of Participants With AEs by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0 Intensity Grades; Percentage of Participants With AEs Leading to Premature Discontinuation of Investigational Medicinal Products (IMPs); Percentage of Participants With AEs of Suspected Cardiac Origin, by New York Heart Association Classification (NYHA); Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Below 50%
Can't join this trial?
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.