SWOG clinical trial number
S1007

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).

Closed
Phase
Accrual
100%
Abbreviated Title
ADJUVANT: Phase III Randomized Endocrine Therapy +/- Chemo according to RS
Status Notes
Step 1 Registration will be closed to accrual effective October 1, 2015 and Step 2 Registration will be closed to accrual effective October 15, 2015.
Activated
01/15/2011
Participants
NCORP, Members, Medical Oncologists, CTSU, Affiliates

Research committees

Breast Cancer

Treatment

Cyclophosphamide 5-Fluorouracil Paclitaxel Docetaxel Doxorubicin Tamoxifen Letrozole Epirubicin Anastrozole

Eligibility Criteria Expand/Collapse

-Pts must have histologically confirmed node + (1-3 nodes) invasive breast carcinoma with + estrogen and/or progesterone receptor status, and be HER2 neg, by IHC or gene amplification evaluation (e.g., FISH/CISH/etc.). If HER2 IHC is 2+, an evaluation for gene amplification must be performed and must not be amplified.
-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 it�s 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).

Publication Information Expand/Collapse

2015

Tumor marker usage and medical care costs among older early-stage breast cancer survivors

S Ramsey;NL Henry;JR Gralow;D Mirick;W Barlow;R Etzioni;D Mummy;R Thariani;D Veenstra Journal of Clinical Oncology 33(2):149-155

PMid: PMID25332254 | PMC number: PMC4279234

2013

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

S Ramsey;W Barlow;A Gonzalez-Angulo;S Tunis;L Baker;J Crowley;P Deverka;D Veenstra;G Hortobagyi Contemporary Clinical Trials 34(1):1-9;

PMid: PMID23000081 | PMC number: PMC3525786

Value of information analysis within a stakeholder-driven research prioritization process in a US setting: an application in cancer genomics

JJ Carlson;R Thariani;J Roth;J Gralow;NL Henry;L Esmail;P Deverka;S Ramsey;L Baker;D Veenstra Medical Decision Making, 33(4):463-471;

PMid: PMID2365833 | PMC number: PMC3933300

Is a comparative clinical trial for breast cancer tumor markers to monitor disease recurrence warranted? A value of information analysis

R Thariani;NL Henry;S Ramsey;DK Blough;W Barlow;J Gralow;D Veenstra Journal of Comparative Effectiveness Research 2(3):325-334

PMid: PMID24236631 | PMC number: PMC4018420

2012

Prioritization in comparative effectiveness research: the CANCERGEN experience in cancer genomics

R Thariani;W Wong;J Carlson;L Garrison;SD Ramsey;P Deverka;L Esmail;S Rangarao;C Hoban;L Baker;D Veenstra Medical Care 50(5):388-393;

PMid: PMID22274803 | PMC number: PMC3469160

The value of comparative effectiveness research: projected return on investment of the RxPONDER trial (SWOG S1007)

W Wong;SD Ramsey;W Barlow;LP Garrison;DL Veenstra Contemporary Clinical Trials 33(6):1117-1123;

PMid: PMID2298189 | PMC number: PMC3486702

Design of a clinical trial for testing the ability of a continuous marker to predict therapy benefit

W Barlow Handbook of Statistics in Clinical Oncology, J Crowley & A Hoering, Editors, 3rd edition, CRC Press, Ch. 19, P. 293-304

PMid: n/a | PMC number: n/a

Stakeholder participation in comparative effectiveness research: defining a framework for efffective engagement

P Deverka;D Lavallee;PJ Desai;L Esmail;S Ramsey;D Veenstra;SR Tunis Journal of Comparative Effectiveness Research 1(2):181-194

PMid: PMID22707880 | PMC number: PMC3371639

2011

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

AM Gonzalez-Angulo;WE Barlow;J Gralow;F Meric-Bernstam;DF Hayes;CM Moinpour;SD Ramsey;A Schott;D Sparks;KS Albain;G Hortobagyi Journal of Clinical Oncology 29: 2011 (suppl; abstr TPS104); ASCO Meeting, TIP poster

Incorporating comparative effectiveness research study endpoints into the treatment for positive node, endocrine responsive breast cancer (RxPonder) study

SD Ramsey;WE Barlow;C Moinpour;A Gonzalez-Angulo;G Hortobagyi;D Veenstra;L Garrison;SR Tunis;LH Baker Journal of Clinical Oncology 29:(suppl; abstr TPS101); ASCO Annual 2011 Meeting, poster presentation.

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

A Gonzalez-Angulo;W Barlow;J Gralow;F Meric-Bernstam;D Hayes;C Moinpour;S Ramsey;A Schott;D Sparks;K Albain;G Hortobagyi San Antonio Breast Cancer Symposium 2011 Meeting, abstract # OT1-03-01;poster presentation;

Designing a randomized trial to test an interaction of treatment and a continuous genomic assay

WE Barlow International Society for Clinical Biostatistics 32nd Annual Meeting (Aug.21-25, Ottawa), invited oral presentation

How comparativeness effectiveness research can help advance "personalized medicine" in cancer treatment

S Ramsey;D Veenstra;S Tunis;L Garrison;J Crowley;L Baker Health Affairs 30(12):2259-2268

PMid: PMID22147853 | PMC number: PMC3477796

Other Clinical Trials

SWOG Clinical Trial Number
SWOG-7436

Combined Modality Therapy of Breast Carcinoma Phase III

Research Committee(s)
Breast Cancer
Activated
01/09/1975
Closed
07/18/1979
Accrual
100%
Closed
Phase
III
Published
SWOG Clinical Trial Number
SWOG-7827

Combined Modality Therapy For Breast Carcinoma Phase III

Research Committee(s)
Breast Cancer
Activated
07/16/1979
Closed
08/01/1989
Accrual
100%
Closed
Phase
III
Published
SWOG Clinical Trial Number
SWOG-8312