SWOG clinical trial number
S0500

A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment

Closed
Phase
III
Accrual
100%
Published
Abbreviated Title
ADVANCED: Therapeutic Strategy Using the CellSearch Assay for Metastatic Breast Cancer
Activated
10/01/2006
Closed
03/15/2012
Participants
NCORP, Members, Medical Oncologists, CTSU Institutions in the United States, Affiliates

Research committees

Breast Cancer

Treatment

CellSearch Assay

Eligibility Criteria Expand/Collapse

Women with histologically confirmed breast cancer and clinical evidence of Stage IV disease; must have measurable disease or bone-only disease (patients whose only disease is non-measurable disease that does not include bone are ineligible). Must be planning to receive chemotherapy. Must not have received any prior chemotherapy for metastatic disease; prior use of hormonal, bisphosphonate, trastuzumab, and/or bevacizumab in the metastatic setting is allowed; may have received any number or type of exogenous hormonal therapies, either for metastatic disease and/or adjuvant therapy; prior adjuvant chemotherapy must be completed at least 12 months prior to registration; must have recovered from any prior surgery; must consent to the CTC blood draw schedule as outlined in the protocol, and submit the initial blood draw within one day of registration; patients who are willing to have their serum banked must provide their consent as outlined in the protocol; PS=0-2; patients with brain metastases must have stable disease >90 days after completing radiotherapy; must not have leptomeningeal disease; pregnant or nursing women are not eligible; no prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, any adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.

Required prestudy labs/scans:
<= 28 days prior to registration (measurable disease):
CT or MRI of the chest & abdomen; whole body bone scan or PET scan; any other x-rays, scans, or physical exams used for tumor measurement.

<=42 days prior to registration (non-measurable disease): X-rays, scan, or physical exams used for tumor assessment

**All patients must have HER-2 status determined by IHC and/or FISH assay.

Publication Information Expand/Collapse

2018

Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials

M Chavez-MacGregor;J Unger;A Moseley;S Ramsey;DL Hershman Cancer Apr 15;124(8):1760-1769; Jan 25 [Epub ahead of print]

PMid: PMID29370458 | PMC number: PMC5963502

Association of Cardiovascular Risk Factors With Cardiac Events and Survival Outcomes Among Patients With Breast Cancer Enrolled in SWOG Clinical Trials

D Hershman;C Till;S Shen;J Wright;S Ramsey;W Barlow;J Unger Journal of Clinical Oncology Mar 27 [Epub ahead of print]

PMid: PMID29584550 | PMC number: PMC Journal - In Process

Survival by Hispanic Ethnicity Among Cancer Patients participating in SWOG Clinical Trials

A Moseley;M Chavez-MacGregor;J Unger;S Ramsey;D Hershman Society for Clinical Trials Annual Meeting (May 20-23 2018, Portland, OR), oral presentation

2017

Association Between Cardiovascular Risk Factors and Cardiac Events Among Breast Cancer Patients Enrolled in SWOG Clinical Trials

D Hershman;C Till;J Wright;S Ramsey;W Barlow;JM Unger San Antonio Breast Cancer Symposium (December 5-9, 2017, San Antonio, TX), poster

2014

SWOG S0500: circulating tumor cells and response to chemotherapy in metastatic breast cancer

J Smerage;W Barlow;GN Hortobagyi;E Winer;B Leyland-Jones;G Srkalovic;S Tejwani;A Schott;M O'Rourke;D Lew;J Gralow;R Livingston;D Hayes Journal of Clinical Oncology 32(31):3483-3489;

PMid: PMID24888818 | PMC number: PMC4209100

2013

SWOG S0500 - a randomized phase III trial to test the strategy of changing therapy versus maintaining therapy for metastatic breast cancer patients who have elevated circulating tumor cell (CTC) levels at first follow-up assessment

J Smerage;W Barlow;D Hayes;E Winer;B Leyland-Jones;G Srkalovic;S Tejwani;A Schott;MA O'Rourke;D Lew;J Gralow;RB Livingston;GN Hortobagyi San Antonio Breast Cancer Symposium, abst. S5-07; oral presentation;

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