Clinical trial · Interventional
S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Measuring blood levels of tumor cells may help in learning how well chemotherapy works to kill metastatic breast cancer cells and allow doctors to plan better treatment. When blood levels of tumor cells are high while receiving chemotherapy, it is not yet known whether it is more effective to change chemotherapy regimens at that time or wait until disease progression. PURPOSE: This randomized phase III trial is studying treatment decision making based on blood levels of tumor cells in women with metastatic breast cancer receiving chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- description
- Patients continue to receive regular treatment without change at the discretion of the physician. Patients are eligible for other first-line chemotherapy trials. No further blood is collected.
- interventionNames
- Drug: chemotherapy
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Patients continue to receive their current chemotherapy regimen without change.
- interventionNames
- Drug: chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Group 3, Arm I
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Clinical evidence of metastatic disease (stage IV disease) * Newly metastatic disease OR progressive metastatic disease while on hormonal therapy * Meets 1 of the following criteria: * Measurable disease * Bone-only disease\* NOTE: \*Patients with nonmeasurable disease that does not include bone are not eligible * HER-2 status determined by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay * HER-2 positivity is defined as IHC 3+ or FISH+ * If IHC is indeterminate (2+), FISH must be performed to classify disease * Planning to undergo first-line chemotherapy for metastatic disease * Patients with brain metastases must have stable disease for \> 90 days after completion of prior radiotherapy to the brain * No leptomeningeal disease * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Zubrod performance status 0-2 * Not pregnant or nursing * Negative pregnancy test * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II cancer currently in complete remission PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior hormonal therapy, bisphosphonate therapy, trastuzumab (Herceptin®), and/or bevacizumab for metastatic disease allowed * Any number of exogenous hormonal therapies for metastatic disease and/or as adjuvant therapy allowed * At least 1 year since prior adjuvant chemotherapy * At least 2 weeks since prior minor surgery and recovered * At least 4 weeks since prior major surgery and recovered * No prior chemotherapy for metastatic disease * Concurrent hormonal therapy and/or bisphosphonate therapy allowed * Concurrent trastuzumab and/or bevacizumab allowed
References
Publications (1)
- DERIVEDSmerage JB, Barlow WE, Hortobagyi GN, Winer EP, Leyland-Jones B, Srkalovic G, Tejwani S, Schott AF, O'Rourke MA, Lew DL, Doyle GV, Gralow JR, Livingston RB, Hayes DF. Circulating tumor cells and response to chemotherapy in metastatic breast cancer: SWOG S0500. J Clin Oncol. 2014 Nov 1;32(31):3483-9. doi: 10.1200/JCO.2014.56.2561. Epub 2014 Jun 2. PMID 24888818