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 was designed to evaluate the utility of adding the 70-gene test (Mammaprint®) to the traditional method of assessing the likelihood of breast cancer recurrence for women with node-negative or 1-to-3 node positive breast cancer.
Mammaprint® is a gene signature using microarray technology that examines 70 breast cancer genes from the tumour with the aim to reveal its potential aggressiveness.
The results of MINDACT were anticipated to help doctors to determine which patients need adjuvant chemotherapy (i.e. treatment given after breast surgery) and which can be spared this additional treatment and its side-effects.
MINDACT is the primary achievement of a broader project called TRANSBIG.
In total 6,693 patients were recruited to MINDACT, the first results of which were published in 2016 in the New England Journal of Medicine (link). The data showed that 46% of the early-stage breast cancer patients identified as high risk for recurrence based on traditional factors were identified as low risk when adding the MammaPrint test. The data demonstrated that chemotherapy provided no clinically meaningful benefit for these patients.
The MINDACT results give hope to many women with node-negative or 1-to-3 node positive early breast cancer: in future, it is possible that about half of the patients who would have received adjuvant chemotherapy in the past according to the traditional method of assessing recurrence risk might avoid 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