Rationale and Design
The current trend in research cancer is to develop ways of individualising breast cancer treatment, so that treatment is tailored to the individual person receiving it. TRANSBIG is therefore working towards:
- better identification of type of systemic (i.e. “that goes to all body”) treatment be it chemotherapy, hormonal or biological therapy - WHICH IS THE BEST TREATMENT?
- better identification of patients who will respond significantly to post-surgery (adjuvant) chemotherapy (vs. those who will not respond significantly) - WHO NEEDS TREATMENT?
The MINDACT trial, ((EORTC 10041/ BIG 3-04) TRANSBIG’s first project, has been set up to mainly answer to that first question. This study will compare the traditional method used to assess risk of the cancer coming back with a new method based on the the tumour gene signature.
The MINDACT (Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy) trial is a multicentre, prospective, phase III trial coordinated by the EORTC (European Organisation for Research and Treatment of Cancer, aisbl) and run under the BIG and TRANSBIG network, which will accrue 6000 node-negative patients.
The study compares the 70-gene prognostic signature, a genomic test developed with micro-array technology, to traditional clinical-pathological methods for assessing the risk of breast cancer recurring in women with lymph node negative disease. It is hypothesized that using the genomic test in addition to traditional methods will result in more accurate risk assessment; if this is proved to be true, it is expected that 10% to 20% of patients with node negative breast cancer will, in the future, safely be able to avoid chemotherapy and its potential side effects.
The MINDACT trial design includes two additional questions related to the best treatment in terms of chemotherapy and hormonal therapy.
Impact of MINDACT on breast cancer care
For more details about MINDACT please check the Frequently Asked Questions, or visit the MINDACT website . You can also contact MINDACT@eortc.be
MINDACT and the 70-gene signature in the news - TRANSBIG's major publications.
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Traditional Method
The
traditional method for assessing the aggressiveness of a cancer or, in other words, the risk of the cancer coming back is based on clinical/pathological criteria’s such as:
the age of the patient, the size of her tumour, the way the tumour cells look under the microscope (called “grade”), and hormone receptors (which are like “ears” on cells that respond to hormones)
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Gene Signature
This
gene signature, commercialised under the name of MAMMAPRINT©, was identified by the Netherlands Cancer Institute and is based on the “microarray” technology. It is like a “fingerprint” of the tumour that defines which genes of your tumour are active or not and it gives the researcher information about your prognosis (that is, the likelihood of your tumour coming back).
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