Treatment Decision Making Based on Blood Levels of Tumor Cells in Women With Metastatic Breast Cancer Receiving Chemotherapy - Full Text View

Sponsor:	Southwest Oncology Group
Collaborators:	National Cancer Institute (NCI) Cancer and Leukemia Group B
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00382018

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Prognostic value of sequentially collected circulating tumor cell (CTC) values [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Correlation of CTC levels with breast cancer tumor markers [ Designated as safety issue: No ]

Estimated Enrollment:	651
Study Start Date:	October 2006
Estimated Primary Completion Date:	September 2011 (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

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Eligibility

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

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

Show 294 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Investigators

Investigator:	Jeffrey B. Smerage, MD, PhD	University of Michigan Cancer Center
Investigator:	Daniel F. Hayes, MD	University of Michigan Cancer Center
Investigator:	Eric P. Winer, MD	Dana-Farber Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Laurence H. Baker, Southwest Oncology Group - Group Chair's Office
ClinicalTrials.gov Identifier:	NCT00382018 History of Changes
Other Study ID Numbers:	CDR0000504319, SWOG-S0500, CALGB-SWOG-S0500
Study First Received:	September 26, 2006
Last Updated:	September 27, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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 February 09, 2012