A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER-2 Negative Breast Cancer with Recurrence Score (RS) of 25 or Less (SWOG S1007) (CIRB)

Conditions

Breast - Female

What is the purpose of this trial?

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 breast cancer with RS ≤ 25 treated with endocrine therapy we will test whether the difference in disease-free survival for patients treated with chemotherapy compared to no chemotherapy depends directly on the magnitude of RS. If benefit depends on the RS score, the trial will determine the optimal cutpoint for recommending chemotherapy or not.


Participation Guidelines

Age:
Gender:

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Sponsor:
Southwest Oncology Group (SWOG)
Dates:
06/13/2011
Last Updated:
Study HIC#:
1104008282