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Meredith M. Regan, ScD
Associate Professor of Medicine,
Department of Biostatistics and Computational Biology
Dana-Farber Cancer Institute and Harvard Medical School
International Breast Cancer Study Group
Goal: To validate clinical recommendations for anti-estrogen treatment in premenopausal women.
Impact: Premenopausal women with early stage, hormone receptor (HR)-positive breast cancer face the possibility that the disease may come back many years after the original diagnosis. Dr. Regan is assessing the long-term effects and survival benefits of anti-estrogen therapies in premenopausal women with HR-positive cancer. Her work will lead to a full understanding of the implications of treatment decisions on overall survival and late side effects of therapy.
What’s next: She and her team are continuing their long-term follow-up of women enrolled in the Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT). They aim to improve the ability to detect the effects of treatment on reducing distant recurrence and improving overall survival and in defining associated late toxicities and side effects of anti-estrogen therapies.
Results from SOFT and TEXT trials led to new guidelines for treatment of hormone receptor (HR)-positive breast cancer in premenopausal women. Follow-up showed a survival benefit with the use of ovarian suppression, particularly for those women who received chemotherapy. With support from BCRF, Dr. Regan and her colleagues will extend the follow-up of women participating in SOFT and TEXT until the year 2020 in order to definitively determine the benefit of ovarian suppression for this group of women.
Full Research Summary
Research area: Assessing the long-term effects and survival benefits of anti-estrogen therapies in premenopausal women who have been treated for estrogen-dependent breast cancers.
Impact: Results from two international clinical trials—the Suppression of Ovarian Function Trial (SOFT) and the Tamoxifen and Exemestane Trial (TEXT)—led to new clinical guidelines for treating women with estrogen receptor (ER)-positive breast cancer in premenopausal women. The initial results from the trials supported the use of ovarian suppression drugs in addition to anti-estrogen therapy to preserve fertility in women who intended to have children after treatment.
However, further follow-up is needed to fully understand the implications of treatment decisions on overall survival and late side effects of therapy. Dr. Regan and her colleagues at the International Breast Cancer Study Group are extending the follow-up of women participating in SOFT and TEXT to a minimum of 10 years for all participants.
What she’s learned so far: Updated SOFT and TEXT results at 8 years of follow-up showed improved survival outcomes for young breast cancer patients treated with ovarian suppression, as compared to tamoxifen alone, with those at higher risk having greater benefit. Women and doctors can now better discuss whether benefits of more intensive treatment are worth the side effects. Longer follow-up remains critical to ensure reduction of late recurrence and understand long-term side effects.
What’s next: Dr. Regan will continue follow-up for another year. A final report is expected in 2021.
Dr. Meredith Regan is Associate Professor of Medicine, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute and Harvard Medical School. She is the Group Statistician for the International Breast Cancer Study Group (IBCSG), a Swiss non-profit research organization dedicated for over 30 years to innovative clinical research to improve treatment options and the quality of life of breast cancer patients.
Since 2003 she has been the lead statistician for the IBCSG’s practice-changing SOFT and TEXT international phase III clinical trials investigating adjuvant endocrine therapies for premenopausal women with hormone receptor-positive early-stage breast cancer. The trials enrolled 5738 premenopausal women in 510 institutions across 27 countries. Together with the trials’ co-chairs, she has led the analysis and reporting of the trials’ primary efficacy results —supporting the use of aromatase inhibitor (AI) with ovarian function suppression (OFS) as a new adjuvant endocrine therapy option for premenopausal women, and clarifying the role of OFS in addition to tamoxifen—as well as the trials quality-of-life, cognitive function and estradiol substudies. She continues in this role as the trials continue to collect longer-term patient follow-up to understand the impact of these therapies on late recurrence and survival and any associated late side effects of the therapies.
Dr. Regan’s research interests extend to clinical-translational investigations to individualize endocrine therapy treatment selection, as well as the statistical analysis of long-term follow-up of randomized trials with selective crossover, motivated by the BIG 1-98 and HERA adjuvant breast cancer trials.
BCRF Investigator Since
The ANN INC. Award (a division of ascena retail group inc.)