What is the MammaPrint® (70 gene signature) test?
MammaPrint® is a gene profile test (a genomic test of breast cancer tumour cells). It examines 70 different genes to look for changes associated with a higher risk of breast cancer recurrence after treatment. The aim of the MammaPrint® test is to help inform decisions about whether to use chemotherapy after local treatment for early breast cancer.
What did MSAC conclude about the MammaPrint® test?
MSAC did not support public (Government) funding for the MammaPrint® test in Australia. This conclusion was based on a review of the safety, clinical effectiveness and cost-effectiveness.
Why did MSAC reach the conclusion not to support public funding of the MammaPrint® test in Australia?
MSAC based its conclusion on its appraisal of a study known as the MINDACT trial which investigated the use of the MammaPrint® test in a clinical trial setting.
The trial aimed to show whether information provided by the MammaPrint® test could be added to existing clinical information to inform decisions about the use of adjuvant chemotherapy for early breast cancer. The trial showed that, overall, breast cancer outcomes were poorer in women who did not have chemotherapy based on the MammaPrint® test, compared with those who received chemotherapy.
“As a result, MSAC had little confidence that the MammaPrint® test could be used to justify withholding chemotherapy without negatively impacting upon important outcomes, including overall survival.” https://breast-cancer.canceraustralia.gov.au/assets/breast/files/MSAC%20Public%20Summary%20Document.pdf
Does this MSAC conclusion apply to other gene profile tests?
MammaPrint® is one gene profile test that has been considered by MSAC for public funding. A number of such tests have been developed to assess the risk of breast cancer recurrence after initial treatment, in order to guide a patient’s decision about the use of chemotherapy.
To date, none of the tests reviewed by MSAC has been considered to provide sufficient evidence of benefit to be approved for public funding in Australia. However, gene profile tests are an active area of research. MSAC’s conclusion in relation to this particular test (MammaPrint®) does not necessarily mean that the Committee would reach the same conclusion for other gene profile tests in the future.
Is the MammaPrint® test available in Australia?
Currently no gene profile tests, including MammaPrint® for use in early breast cancer, are publicly funded in Australia, however patients can choose to personally pay for such a test.
Patients who choose to undertake the MammaPrint® test after being informed about the MSAC findings, should be made aware that there is an out of pocket cost for the test. This is called informed financial consent. Patients should also be made aware that breast cancer tissue is sent overseas for testing.
What should I do if I am considering having the MammaPrint® test to inform my decision about whether to have chemotherapy?
There are many factors considered in the decision whether or not to have chemotherapy in each individual case.
Talk to your specialist treating clinician about the potential benefits and risks of chemotherapy for you, based on available clinical information about you and your breast cancer, and the MSAC conclusion on use of the MammaPrint® test.
In order that you make the decision that is right for you, it is important you understand what is involved, including the cost of having the test.
What if I have had the MammaPrint® test?
If you have had the MammaPrint® test, you may have used the results to help you decide whether or not to have chemotherapy. Treatment decisions are based on the best available information at the time. There are many factors considered in the decision whether or not to have chemotherapy in your case, including specific clinical and tumour characteristics.
If you have questions or concerns associated with the use of the MammaPrint® test in your case, speak to your specialist treating clinicians.