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 burdensome side effects for some women.
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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.
These trials gave women with ER-positive early breast cancer more treatment options than tamoxifen alone, and hence contribute to improving the quality of life for countless women around the globe, an important step forward towards personalised treatments for women with ER-positive disease.
These trials were all run under the BIG umbrella with BIG 1-97/MA.17 being coordinated by the National Cancer Institute of Canada Clinical Trials Group, BIG 2-97 IES by the International Collaborative Cancer Group, and BIG 1-98 by the International Breast Cancer Study Group.