SWOG S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less

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SWOG S1007: A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less

Primary Obj. - to determine the effect of chemotherapy in patients with node positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX. In patients with 1-3 positive nodes, and hormone receptor (HR)-positive, HER2-negative brest cancer with RS < or equal to 25 treated with endocrine therapy we will test whether the difference in disease-free survival for patients treated with chemo compared to no chemo depends directly on the magnitude of RS. If benefit depends on the RS score, the trial will determine the optimal cutpoint for recommending chemo or not.

Protocol Number041105
Principal InvestigatorDeborah Toppmeyer
PhasePhase III
ScopeNational
Applicable Disease SitesBreast - Female
Participating InstitutionsThe Cancer Institute of New Jersey
Robert Wood Johnson University Hospital at Hamilton
Robert Wood Johnson University Hospital in New Brunswick

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.