A Randomized Phase III Trial of the Value
- Slides: 51
A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer: ECOG-ACRIN 2108 Presented By Seema Khan at TBD
Background Presented By Seema Khan at TBD
Completed randomized trials testing the value of LRT in de novo Stage IV breast cancer have provided conflicting data Presented By Seema Khan at TBD
Design of E 2108 Opened in 2011, last patient enrolled in 2015. Presented By Seema Khan at TBD
Endpoints Presented By Seema Khan at TBD
Consort diagram Presented By Seema Khan at TBD
Results: participant characteristics. Presented By Seema Khan at TBD
Results: distant disease patterns and initial systemic therapy used. Presented By Seema Khan at TBD
Results: primary tumor characteristics. Presented By Seema Khan at TBD
Results: characteristics of randomized participants, by arm. Presented By Seema Khan at TBD
Delivery of locoregional therapy in early local therapy arm Presented By Seema Khan at TBD
Results: overall survival Presented By Seema Khan at TBD
Results: progression-free survival Presented By Seema Khan at TBD
Results: overall survival by tumor subtype Presented By Seema Khan at TBD
Locoregional progression. Presented By Seema Khan at TBD
Results: health-related quality of life. Presented By Seema Khan at TBD
Conclusions Presented By Seema Khan at TBD
MINDACT: Long-term results of the large prospective trial testing the 70 -gene signature Mamma. Print as guidance for adjuvant chemotherapy in breast cancer patients Presented By Fatima Cardoso at TBD
Slide 2 Presented By Fatima Cardoso at TBD
Slide 3 Presented By Fatima Cardoso at TBD
SECONDARY ENDPOINT Presented By Fatima Cardoso at TBD
Slide 5 Presented By Fatima Cardoso at TBD
MINDACT successfully met its primary endpoint SUMMARY OF CONCLUSIONS OF PRIMARY ANALYSIS (5 y median FU) Presented By Fatima Cardoso at TBD
UPDATED ANALYSIS AT 8. 7 YEARS MEDIAN FOLLOW-UP RESULTS Presented By Fatima Cardoso at TBD
MINDACT CURRENT MEDIAN FOLLOW-UP >90% patients followed-up for at least 5 years, median 8. 7 years Presented By Fatima Cardoso at TBD
Events across the entire MINDACT population Median follow-up = 8. 7 years Presented By Fatima Cardoso at TBD
Update of PRIMARY ENDPOINT with more mature data at 5 years (>90% of pts with at least 5 years FU) Presented By Fatima Cardoso at TBD
At 8. 7 y median FU, DMFS in 4 risk groups Excellent prognosis and low rate of events in all groups except Clinical High/Genomic High Presented By Fatima Cardoso at TBD
SECONDARY ENDPOINT DMFS C-High/G-Low risk (ITT population) CT vs no CT Presented By Fatima Cardoso at TBD
SECONDARY ENDPOINT C-High/G-Low risk (ITT population) CT vs no CT ITT analysis Presented By Fatima Cardoso at TBD
Effect of chemotherapy by age in HR+/HER 2 - subgroup C-High/G-Low group Presented By Fatima Cardoso at TBD
DMFS in C-High / G-Low risk patients with luminal cancers (HR+/HER 2 -) stratified by age ITT population Presented By Fatima Cardoso at TBD
DMFS in C-High / G-Low risk patients with luminal cancers (HR+/HER 2 -) stratified by age ITT population Presented By Fatima Cardoso at TBD
Slide 17 Presented By Fatima Cardoso at TBD
Slide 18 Presented By Fatima Cardoso at TBD
KEYNOTE-355: Randomized, Double-Blind, Phase 3 Study of Pembrolizumab + Chemotherapy versus Placebo + Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer Presented By Javier Cortes at TBD
Pembrolizumab Monotherapy in m. TNBC Presented By Javier Cortes at TBD
Pembrolizumab Plus Chemotherapy Presented By Javier Cortes at TBD
KEYNOTE-355 Study Design (NCT 02819518) Presented By Javier Cortes at TBD
Study Endpoints Presented By Javier Cortes at TBD
Statistical Considerations Presented By Javier Cortes at TBD
Treatment Disposition of All Randomized Patients Presented By Javier Cortes at TBD
Baseline Characteristics, ITT Presented By Javier Cortes at TBD
Progression-Free Survival: PD-L 1 CPS ≥ 10 Presented By Javier Cortes at TBD
Progression-Free Survival: PD-L 1 CPS ≥ 10 Presented By Javier Cortes at TBD
Progression-Free Survival: PD-L 1 CPS ≥ 1 Presented By Javier Cortes at TBD
Progression-Free Survival: ITT Presented By Javier Cortes at TBD
Progression-Free Survival in PD-L 1 CPS Subgroups Presented By Javier Cortes at TBD
Progression-Free Survival in Subgroups: PD-L 1 CPS ≥ 10 Presented By Javier Cortes at TBD
Immune-Mediated AEs Presented By Javier Cortes at TBD
Summary Presented By Javier Cortes at TBD
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