A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone-responsive and Her2-Negative Breast Cancer according to Recurrence Score (RS).
Step 1 Registration was closed to accrual effective October 1, 2015 and Step 2 Registration was closed to accrual effective October 15, 2015.
Eligibility Criteria Expand/Collapse
-Patients with multifocal, multicentric and synchronous bilateral breast cancers are allowed.
-Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant.
-Multicentric disease is defined as more than one invasive cancer >/= 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants.
-Synchronous bilateral disease is defined as invasive breast cancer with + lymph nodes in at least one breast, diagnosed within 30 days of each other.
-Pts will have undergone axillary staging by sentinel node biopsy or axillary lymph node dissection. Pts must have at least one, but no more than three known + lymph nodes.
-Pts must not have inflammatory breast cancer and must not have metastatic disease. Pts with prior DCIS diagnosis are eligible if they received mastectomy alone. Pts must have had either breast-conserving surgery with planned radiation or total mastectomy and must have clear margins.
-Pts must have had either breast-conserving surgery w/planned radiation or mastectomy and have clear margins.
-Reg of patients who have not had had Ocotype DX screening must be no later than 56 days after surgery. If not performed, pts must submit tissue samples for testing to determine Recurrence Score value. If score is known and </= 25, pts must be registered to Step 2 immediate after Step 1 reg. if > 25, pt is ineligible.
-Pts must be female >/= 18 yrs of age.
-Pts must have PS 0-2.
-Pts must be able to receive Taxane and/or anthracycline based chemo.
-Pts must not have begun chemo or endocrine therapy for breast cancer.
-Pts must not require chronic systemic steroid or other immunosuppressants.
-Pts must not have received preventive tamoxifen or raloxifene, or have prior therapeutic ipsilateral breast radiation, unless itï¿½s partial breast irradiation for index tumor.
-Pts must not be pregnant or nursing.
-No prior malignancy is allowed except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage 0-2 cancer from which the pt is in CR or any other cancer from which the pt has been disease free for 5 yrs.
-Pts must be offered QOL Economic Substudy.(if able to complete English questionnaire).
STEP 3 REGISTRATION:
U.S. Patients who meet the following criteria at time of participating site activation of Revision 16 (Version Date 03/24/21) must be offered participation in sample collection and banking, as indicated in Section 15.3, for the Circulating Biomarker Assessment for Late Relapse Translational Medicine Substudy:
a. Patients must be disease-free, with no prior invasive recurrence at time of registration to Step 3.
b. Patients must be registered to Step 3 no more than 8 years after randomization (Step 2 Registration) and must agree to have samples drawn within 28 days after registration to Step 3.
c. Patients must agree to have blood samples collected at up to 3 timepoints: 1) within 28 days after registration to Step 3, 2) 2-3 years after time of registration to Step 3, and 3) At time of invasive recurrence (if applicable). Patients must also agree to have tissue submitted at time of invasive recurrence (if applicable) from the invasive recurrence biopsy (where tissue is available).
** NOTE: Specimen collection kits must be ordered IMMEDIATELY after patient registration to Step 3. See Section 15.3b for kit ordering instructions.
Publication Information Expand/Collapse
Distant-Disease Free Interval in participants (pts) with 1-3 positive lymph nodes (LN), hormone receptor-positive (HR+) and HER2-negative (HER2-) breast cancer (BC) with recurrence score (RS) < 25 randomized to endocrine therapy (ET) +/- chemotherapy (CT): SWOG S1007 (RxPONDER)
PMid: PMID25332254 | PMC number: PMC4279234
Integrating comparative effectiveness design elements and endpoints into a phase III, randomized clinical trial (SWOG S1007) evaluating OncotypeDX-guided management for women with breast cancer involving lymph nodes
PMid: PMID23000081 | PMC number: PMC3525786
PMid: PMID2365833 | PMC number: PMC3933300
PMid: PMID24236631 | PMC number: PMC4018420
PMid: PMID22274803 | PMC number: PMC3469160
PMid: PMID2298189 | PMC number: PMC3486702
Design of a clinical trial for testing the ability of a continuous marker to predict therapy benefit
PMid: n/a | PMC number: n/a
PMid: PMID22707880 | PMC number: PMC3371639
SWOG S1007: a phase III, randomized clinical trial of standard adjuvant endocrine therapy +/- chemotherapy in patients with 1-2 positive nodes, hormone receptor (HR)-positive and HER2-negative breast cancer with recurrence score (RS) of 25 or less
Incorporating comparative effectiveness research study endpoints into the treatment for positive node, endocrine responsive breast cancer (RxPonder) study
A randomized phase III clinical trial of standard adjuvant endocrine therapy in patients (pts) with 1-3 positive nodes, hormone receptor (HR)-positive and HER-2negative breast cancer with recurrence score (RS) of 25 or less: SWOG S1007
Designing a randomized trial to test an interaction of treatment and a continuous genomic assay
PMid: PMID22147853 | PMC number: PMC3477796