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
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
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.
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
2023
PMid: PMID36634296 | PMC number: PMC9928629
2022
The application of ACCEPT software in retrospective analysis of specimen data (SWOG S0500 Translational Medicine Project)
2020
PMid: PMID32306168 | PMC number: PMC8218818
2019
PMid: PMID31358544 | PMC number: PMC6801082
2018
Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials
PMid: PMID29370458 | PMC number: PMC5963502
PMid: PMID29584550 | PMC number: PMC6127026
2017
History of diabetes and outcome among participants 65 or older in SWOG clinical trials
PMid: PMID30657402 | PMC number: PMC6640843
2014
SWOG S0500: circulating tumor cells and response to chemotherapy in metastatic breast cancer
PMid: PMID24888818 | PMC number: PMC4209100
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Research Committee(s)
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Activated
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Research Committee(s)
Breast Cancer
Activated
06/07/2021
Open
Phase