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 ran in two parts and looked at how participants' tumours responded to treatment. In Part A, 26 people started taking afatinib (a tablet taken once a day) on its own, and 10 of them went on to Part B. In Part B, those 10 people received afatinib combined with another medicine called vinorelbine. The trial was mainly measuring something called "clinical benefit" — which the researchers defined as a tumour either shrinking (a partial or complete response) or staying stable for at least six months, based on a standard system for measuring tumour size called RECIST 1.1. The reported data shows that in Part A, 35% of participants were recorded as achieving clinical benefit on afatinib alone. In Part B, 20% of participants were recorded as achieving clinical benefit on the combination of afatinib and vinorelbine. For a secondary measure — looking only at confirmed tumour shrinkage (partial or complete response) — the reported figures were 31% in Part A and 10% in Part B. When unconfirmed responses were also included, the reported figures were 42% in Part A and 30% in Part B. Because Part B involved only 10 people, these percentages represent very small numbers of individuals. It is worth noting that this was a small trial with a limited number of participants, particularly in Part B, so the reported percentages each represent only a handful of people. The reported data shows what was observed and measured during the trial; it does not tell us how these results compare to other treatments or what they would mean for any individual person. 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
Who may 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 might be able to join this trial:
- You are a woman aged 18 or older with a confirmed diagnosis of breast cancer that has too much of a protein called HER2 (which helps cancer cells grow)
- Your breast cancer has either spread to nearby areas or to other parts of the body
- Your cancer can be measured and tracked using standard imaging methods, according to specific guidelines (called RECIST 1.1)
- If you have previously been treated with a drug called trastuzumab (Herceptin), your cancer must have continued to grow or stopped responding to that treatment
- Your doctor has confirmed you have a specific type of breast cancer called Inflammatory Breast Cancer
- You have areas of cancer that can be safely sampled with a biopsy
Who may not be able to join:
- You have previously received any HER2-targeted treatments (drugs or antibodies that target the HER2 protein) other than trastuzumab
- You have previously been treated with a chemotherapy drug called vinorelbine
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 is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).; Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Can't join this trial?
Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.