Dr. Meredith Regan Visits Frontier Science To Present IBCSG Trial Results

Meredith Regan, Sc.D., Director of the Statistical and Data Management Center for the International Breast Cancer Study Group (IBCSG) and co-lead for the IBCSG TEXT and SOFT Trials, visited Frontier Science to present the results of several trials. These results were recently presented during the San Antonio Breast Cancer Symposium (SABCS 2017).

Dr Meredith Regan

IBCSG trial information presented to Frontier Science staff includes the following:

IBCSG 23-01 SNB Trial: Axillary Dissection vs No Axillary Dissection in Patients with cT1-T2 NO Breast Cancer and Micrometastases Only in the Sentinel Node
Update Results: The international randomized Phase III trial IBCSG 23-01 compared disease-free survival of breast cancer patients with one or more micrometastatic (=2 mm) sentinel lymph nodes (SNs), hypothesizing that omission of axillary dissection (no-AD) would be non-inferior to axillary dissection (AD). Results after 5 years median follow-up showed no difference in DFS between the groups. A final report of results after a median follow-up of 10 years fully supported the findings at 5 years, confirming that AD in patients with micrometastatic SNs is not indicated.

The SOFT and TEXT international randomized Phase III trials investigate adjuvant endocrine therapy for premenopausal women with early breast cancer. The trial results were first presented in 2014, after a median follow-up of about 5.5 years. The results were updated after a median follow-up of about 8.5 years and presented at the 2017 SABCS. Follow-up continues.

IBCSG 24-02/BIG 2-02 SOFT Trial: Randomized Comparison of Adjuvant Tamoxifen plus Ovarian Function Suppression vs Tamoxifen in Premenopausal Women with HR+ Early Breast Cancer
Update Results: The first presentation of the primary results of SOFT found adding ovarian function suppression (OFS) to tamoxifen did not provide a significant benefit in terms of reducing recurrence in the overall study population, but found benefit for those at higher risk of recurrence. After longer follow-up, a significant reduction in recurrence with the addition of OFS to tamoxifen and a small overall survival benefit were observed in the groups of premenopausal women assigned ovarian suppression after adjuvant chemotherapy.

Combined IBCSG 24-02/BIG 2-02 SOFT and IBCSG 25-02/BIG 3-02 TEXT Trials: Randomized Comparison of Adjuvant Aromatase Inhibitor Exemestane plus Ovarian Function Suppression vs Tamoxifen plus Ovarian Function Suppression in Premenopausal Women with HR-positive Early Breast Cancer
Update Results: The first presentation of a combined analysis of TEXT and SOFT found adjuvant exemestane+OFS significantly reduced recurrence versus tamoxifen+OFS in this population. After longer follow-up, this benefit persisted and the reduction specifically in distant recurrence was clinically-meaningful for those patients who had indication to also receive adjuvant chemotherapy.

IBCSG 45-13/BIG 4-13 PANACEA Trial: Phase Ib/II Study Evaluating Safety and Efficacy of Pembrolizumab and Trastuzumab in Patients with Trastuzumab-Resistant HER2-Positive Advanced Breast Cancer
Final Results: The PANACEA Trial is an international Phase Ib/II study to evaluate the safety and efficacy of using immunotherapy with pembrolizumab in combination with the standard therapy trastuzumab in patients with HER2-positive metastatic breast cancer. In 42 patients with PD-L1-positive tumors, the trial met its primary objective, observing an objective response rate of 15% and a disease control rate of 25%. The results suggest that the PD-1/PD-L1 pathway plays an important role in the trastuzumab resistance that is seen in patients with metastatic HER2-positive breast cancer, and the PANACEA Trial provides proof-of principle evidence that PD-1 inhibition like pembrolizumab can help reverse this.

IBCSG 41-13 TREND Trial: Randomized Phase II Trial Evaluating the Endocrine Activity and Efficacy of Neoadjuvant Degarelix vs Triptorelin in Premenopausal Patients Receiving Letrozole for Primary Endocrine Responsive Breast Cancer
Final Results: The Phase II TREND Trial evaluated the endocrine activity, in terms of ovarian function suppression (OFS) of degarelix (GnRH antagonist) vs. triptorelin (GnRH agonist), in premenopausal patients receiving letrozole as neoadjuvant endocrine therapy for breast cancer. The results found degarelix allowed faster OFS and maintained optimal OFS as compared to triptorelin.

Dr. Reagan is also Associate Professor of Medicine, Department of Biostatistics & Computational Biology, Dana-Farber Cancer Institute (DFCI) and Harvard Medical School. She earned her doctorate in biostatistics at the Harvard School of Public Health.

Additionally, Dr. Regan is a member of the US National Cancer Institute (NCI) Breast Cancer Steering Committee and the Early Breast Cancer Trialists Collaborative Group Steering Committee. She has also held leadership roles within the DFCI and Dana-Farber/Harvard Cancer Center (DF/HCC) genitourinary cancers programs for nearly 20 years. Her research focuses on clinical and translational research to inform patient care and treatment selection for breast and genitourinary cancers.

Trial Information