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A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00355316
First received: July 19, 2006
Last updated: June 19, 2013
Last verified: June 2013

July 19, 2006
June 19, 2013
November 2005
November 2012   (final data collection date for primary outcome measure)
The prevalence of breast cancer cells in the peripheral blood [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Specifically, it is predicted that 60% of subjects with Stage IV breast cancer will have evidence of breast cancer cells in the peripheral blood by multi-marker real-time RT-PCR analysis, and that these subjects will experience a significantly decreased progression-free and overall survival.
The prevalence of breast cancer cells in the peripheral blood
Complete list of historical versions of study NCT00355316 on ClinicalTrials.gov Archive Site
  • Evaluate the prognostic significance of molecular detection of breast cancer cells in peripheral blood after initiation of systemic therapy. [ Time Frame: Until patient death ] [ Designated as safety issue: No ]
    Specifically, we will determine if molecular detection of circulating breast cancer cells after the initiation of systemic therapy is associated with a significantly decreased progression-free and overall survival.
  • Quantify baseline molecular marker expression levels in the peripheral blood of healthy volunteers [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]
    Determine if baseline molecular marker expression levels are dependent on patient age, race, and/or the presence of benign breast disease.
  • Compare molecular analyses to the results of the CellSeach assay [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]
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A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients
Peripheral Blood Molecular Staging of Breast Cancer: A Prospective Cohort Study Designed to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Peripheral Blood of Stage IV Breast Cancer Patients

This study is designed to determine whether molecular detection of breast cancer cells in the peripheral blood of Stage IV breast cancer patients is a clinically relevant predictor of progression-free and overall survival. Stage IV breast cancer patients who have measurable breast cancer metastases and are initiating a regimen of systemic therapy are eligible for enrollment. Multi-marker real-time RT-PCR analysis will be performed on peripheral blood specimens from 92 breast cancer patients and 120 healthy volunteers. Peripheral blood specimens from breast cancer patients will be obtained at the time of study entry (prior to initiation of systemic therapy) and at serial time points during follow-up. Subjects will be followed longitudinally until death, although the study has been powered so that the primary objective can be addressed after 12 months of follow-up. Healthy volunteers will be asked to provide a blood sample at time of enrollment but will not be followed.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Breast Neoplasms
Other: Blood draw
  • Experimental: Stage IV Breast Cancer
    Blood draws at baseline before systemic therapy. Blood draw then every 6 weeks for approximately 12 weeks.
    Intervention: Other: Blood draw
  • Healthy Volunteers
    Baseline blood draw.
    Intervention: Other: Blood draw

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
224
February 2013
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inclusion Criteria - Stage IV breast cancer patients

  1. Patient age must be > 21 years.
  2. Patient must have a tissue diagnosis of invasive breast cancer.
  3. Patient must have documented evidence of metastatic disease.
  4. Patient must have measurable lesions.
  5. Patients must be initiating systemic therapy. Patients receiving hormonal therapy, and/or chemotherapy alone or in combination with other therapies are eligible.
  6. Patient must have an ECOG performance status of 0, 1, or 2.
  7. Patient must be available for follow-up.
  8. Patient or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
  9. The patient with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patients have been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).

Inclusion Criteria - Healthy volunteers

A volunteer will be eligible for inclusion in this study only if ALL of the following criteria apply:

  1. Volunteer age must be > 21 years.
  2. Volunteer or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
  3. Patients with benign breast disease are eligible for enrollment.
  4. The volunteer with a previous history of non-breast malignancy is eligible for this study only if the patient meets the following criteria for a cancer survivor. A cancer survivor is eligible provided both of the following criteria are met: (1) patient has undergone potentially curative therapy for all prior malignancies, (2) patient has been considered disease free for at least 5 years (with the exception of basal cell or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix).

Exclusion Criteria:

Exclusion Criteria - Stage IV breast cancer patients

A patient will be ineligible for inclusion in this study if ANY of the following criteria apply:

  1. No documented metastatic disease.
  2. No measurable lesions.
  3. Bone only and/or brain metastasis.
  4. Patient is not initiating a new regimen of systemic therapy.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00355316
05-0435 / 201109033
No
Washington University School of Medicine
Washington University School of Medicine
National Institutes of Health (NIH)
Principal Investigator: William E. Gillanders, M.D. Washington University School of Medicine
Washington University School of Medicine
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP