S0500 Treatment Decision Making Based on Blood Levels of Tumor Cells in Women With Metastatic Breast Cancer Receiving Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cancer and Leukemia Group B
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00382018
First received: September 26, 2006
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Every 3 months until progression then every 6 months for 5 years or until death ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: every 3 months until progression ] [ Designated as safety issue: No ]
  • Prognostic value of sequentially collected circulating tumor cell (CTC) values [ Time Frame: Baseline, Weeks 4, 8, 13, 25, 37 and at progression ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: Weeks 3 and 6 and then every 6 weeks until progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Correlation of CTC levels with breast cancer tumor markers [ Time Frame: Baseline, Weeks 4, 8, 13, 25, 37 and at progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 651
Study Start Date: October 2006
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
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.
Drug: chemotherapy
No administration details available
Experimental: Group 2
Patients continue to receive their current chemotherapy regimen without change.
Drug: chemotherapy
No administration details available
Active Comparator: Group 3, Arm I
Patients continue with their current chemotherapy regimen without change.
Drug: chemotherapy
No administration details available
Experimental: Group 3, Arm II
Patients switch to a different chemotherapy regimen. Selection of a new chemotherapy regimen is made by the patient's doctor.
Drug: chemotherapy
No administration details available

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382018

  Show 296 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Cancer and Leukemia Group B
Investigators
Study Chair: Jeffrey B. Smerage, MD, PhD University of Michigan Cancer Center
Study Chair: Daniel F. Hayes, MD University of Michigan Cancer Center
Study Chair: Eric P. Winer, MD Dana-Farber Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00382018     History of Changes
Other Study ID Numbers: CDR0000504319, S0500, U10CA032102
Study First Received: September 26, 2006
Last Updated: May 22, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014