Several of BIG’s trials are considered to be landmark, introducing particularly innovative designs, contributing to significant breakthroughs, or paving the way towards more personalised treatment of the disease.
HERA: a new standard of treatment
Recruiting 5.100 women from 480 sites across 39 countries in just over four years – in itself a remarkable achievement – HERA contributed to a new standard of treatment for women with HER2-positive, early breast cancer, a highly aggressive form of the disease. HERA helped accelerate the approval of a drug, trastuzumab, that has cut relapse rates by 50% and is now the standard treatment for this type of breast cancer.
The effectiveness of aromatase inhibitors
Three studies, BIG 1-97/MA.17, BIG 2-97/IES and BIG 1-98, together recruiting a total of 17.958 patients, contributed to the body of evidence that aromatase inhibitors could be used as a safe alternative to tamoxifen, a drug used to treat oestrogen receptor (ER) positive breast cancer that is associated with dangerous side effects for some women. Not only did these trials prove the effectiveness of the new drugs, but they also answered important additional questions about whether the drugs should be given in combination or in sequence with others, the likelihood of side effects with long-term use, and patients’ overall quality of life.
MINDACT: who can be spared chemotherapy ?
The MINDACT study has been designed to evaluate the microarray analysis (Mammaprint®) by comparing this technology with the traditional method of deciding whether chemotherapy should be prescribed after surgery to avoid the risk of relapse.
MINDACT is the primary achievement of a broader project called TRANSBIG.
The study has been conducted on women with node negative breast cancer and women with 1 to 3 positive lymph nodes. The microarray test was expected to identify, more reliably than traditional methods, the more aggressive tumours requiring additional treatment.
The results of MINDACT were anticipated to help doctors to identify which women do need chemotherapy due to the tumour aggressiveness and which women can be spared this additional treatment after surgery.
In total 6.693 patients were recruited in the MINDACT trial. The first results of which were presented in 2016. They give hope to many women with early-stage breast cancer: in future, it is possible that up to 46% of patients who would have received chemotherapy in the past can be spared from this treatment and its side-effects.
AURORA: uncovering the molecular landscape of metastatic breast cancer
Launched in April 2014, AURORA uses molecular screening to improve our understanding of metastatic breast cancer and its response or lack of response to available drug therapies. In total 1300 women and men from about 60 hospitals in 15 European countries are expected to take part in the programme. Metastatic and primary breast cancer tissue specimens will be collected and screened for the first time on an international scale. By uncovering the mechanisms underlying metastasis, scientists will be able to develop more personalised treatments for patients in the future.
Think BIG - Real progress in the fight against breast cancer