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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 is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00355316
First received: July 19, 2006
Last updated: December 20, 2012
Last verified: December 2012
History of Changes

July 19, 2006
December 20, 2012
November 2005
May 2013   (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 ]
The prevalence of breast cancer cells in the peripheral blood
Complete list of historical versions of study NCT00355316 on ClinicalTrials.gov Archive Site
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Not Provided
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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.

Enrollment Stage IV breast cancer patients who have measurable breast cancer metastases and are initiating a regimen of systemic therapy are eligible for enrollment.

Phlebotomy Peripheral blood will be obtained from all subjects at the time of initial enrollment, and at serial time-points during follow-up. The first specimen will be drawn prior to the initiation of systemic therapy, and subsequent specimens will be obtained approximately every 6 weeks for approximately 12 weeks depending on the type and schedule of systemic therapy. Results of molecular analyses will not be available to clinical investigators.

Systemic Therapy Subjects initiating hormone therapy, chemotherapy, and/or immunotherapy are eligible for participation.

Restaging Results of patient imaging obtained as part of standard clinical care will be collected as available.

Survival Analysis Subjects will be followed for at least one year following enrollment. All clinical and radiographic data will be reviewed in order to determine the clinical response to therapy. Kaplan-Meier survival estimates will be compared with log-rank testing.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, tissue.
Non-Probability Sample

Primary care clinic and healthy volunteers.
Breast Neoplasms
  • Other: Blood draw
    Blood draws before starting treatment, then monthly for two to three months. If patient is receiving chemotherapy as standard care, they will have blood drawn prior to cycles 1, 2, and 3(approximately every 3-4 weeks for 8-10 weeks, for a total of 3 blood draws). If patients are receiving hormone therapy as standard care, they will have blood drawn prior to beginning treatment, and then approximately every 6 weeks for 12 weeks (3 blood draws total).
  • Other: Blood draw
    One tablespoon of blood will be drawn one time.
  • 1
    Patients with Stage IV breast cancer.
    Intervention: Other: Blood draw
  • 2
    Healthy Volunteers
    Intervention: Other: Blood draw

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
212
May 2013
May 2013   (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 first-,second-, or third-line 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. Patients with benign breast disease are defined as those patients who are scheduled to undergo a breast tissue sampling procedure. Breast tissue sampling procedures may include fine needle aspiration biopsy, core needle biopsy, including image-guided core needle biopsy, and open surgical biopsy including needle-localization biopsy, and/or excisional biopsy.
  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.
  5. Patient has failed 3 regimens of chemotherapy for metastatic disease, not including adjuvant 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
December 2012

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