We enrolled women who were at least 18 years of age and who had hormone-receptor–positive,11 (link) HER2-negative,12 (link) nodal stage N1, noninflammatory breast cancer without distant metastasis.13 (link) The participants had to have undergone primary surgery with sentinel-node biopsy or axillary lymph-node dissection and had to be eligible for a chemotherapy regimen that contained a taxane, an anthracycline, or both.
Premenopausal status was defined as less than 6 months since the last menstrual period, and postmenopausal status was defined as previous bilateral oophorectomy or more than 12 months since the last menstrual period and no previous hysterectomy. If these definitions did not apply, participants were categorized as premenopausal if they were younger than 50 years of age and as postmenopausal if they were 50 years of age or older. Full entry criteria and approved options for chemotherapy and endocrine therapy are listed in the protocol.
A representative block or unstained sections of the primary invasive tumor were sent directly to Genomic Health for testing according to standard commercial processing. Women with a recurrence score higher than 25 were ineligible for the trial, and it was recommended that they receive adjuvant chemoendocrine therapy. Women with a recurrence score of 0 to 25 were invited to participate in the trial. Participants who provided consent were randomly assigned in a 1:1 ratio to receive chemoendocrine therapy or endocrine therapy only. The stratification factors included the recurrence score (0 to 13 or 14 to 25), premenopausal or postmenopausal status, and type of axillary surgery (sentinel-node biopsy or axillary lymph-node dissection). Each participant was to be followed for 15 years after randomization.
Premenopausal status was defined as less than 6 months since the last menstrual period, and postmenopausal status was defined as previous bilateral oophorectomy or more than 12 months since the last menstrual period and no previous hysterectomy. If these definitions did not apply, participants were categorized as premenopausal if they were younger than 50 years of age and as postmenopausal if they were 50 years of age or older. Full entry criteria and approved options for chemotherapy and endocrine therapy are listed in the protocol.
A representative block or unstained sections of the primary invasive tumor were sent directly to Genomic Health for testing according to standard commercial processing. Women with a recurrence score higher than 25 were ineligible for the trial, and it was recommended that they receive adjuvant chemoendocrine therapy. Women with a recurrence score of 0 to 25 were invited to participate in the trial. Participants who provided consent were randomly assigned in a 1:1 ratio to receive chemoendocrine therapy or endocrine therapy only. The stratification factors included the recurrence score (0 to 13 or 14 to 25), premenopausal or postmenopausal status, and type of axillary surgery (sentinel-node biopsy or axillary lymph-node dissection). Each participant was to be followed for 15 years after randomization.
