S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells for Metastatic Breast Cancer Treated With Chemo

NCT00382018 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2017-11-06

Study results available
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Summary

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

Interventions

DRUG

chemotherapy

No administration details available

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • Cancer and Leukemia Group B

    collaborator NETWORK
  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Jeffrey B. Smerage, MD, PhD · University of Michigan Rogel Cancer Center

  • Daniel F. Hayes, MD · University of Michigan Rogel Cancer Center

  • Eric P. Winer, MD · Dana-Farber Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2015-12-31
Completion
2017-07-11

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00382018 on ClinicalTrials.gov