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

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 currently recruiting participants.
Study NCT00355316 Information provided by Washington University School of Medicine
First Received: July 19, 2006 Last Updated: October 19, 2009 History of Changes

Tracking Information
First Received Date ICMJE July 19, 2006
Last Updated Date October 19, 2009
Start Date ICMJE November 2005
Estimated Primary Completion Date November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE
(submitted: January 16, 2008) The prevalence of breast cancer cells in the peripheral blood [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJE
(submitted: July 19, 2006) The prevalence of breast cancer cells in the peripheral blood
Change History Complete list of historical versions of study NCT00355316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE
Original Secondary Outcome Measures ICMJE

Descriptive Information
Brief Title ICMJE A Study to Determine the Clinical Significance of Molecular Detection of Breast Cancer in the Blood of Stage IV Breast Cancer Patients
Official Title ICMJE 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
Brief Summary 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.

Detailed Description 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.

Study Phase
Study Type ICMJE Observational
Study Design ICMJE Case Control, Prospective
Condition ICMJE Breast Neoplasms
Intervention ICMJE 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.
Study Arms / Comparison Groups 1
Patients with Stage IV breast cancer.
Intervention: Other: Blood draw
2
Healthy Volunteers
Intervention: Other: Blood draw

Recruitment Information
Recruitment Status ICMJE Recruiting
Estimated Enrollment ICMJE 212
Estimated Completion Date November 2010
Estimated Primary Completion Date November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ICMJE Inclusion Criteria:

Inclusion Criteria - Stage IV breast cancer patients

Patient age must be > 21 years.
Patient must have a tissue diagnosis of invasive breast cancer.
Patient must have documented evidence of metastatic disease.
Patient must have measurable lesions.
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.
Patient must have an ECOG performance status of 0, 1, or 2.
Patient must be available for follow-up.
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.
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:

Volunteer age must be > 21 years.
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.
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.
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:

No documented metastatic disease.
No measurable lesions.
Bone only and/or brain metastasis.
Patient is not initiating a new regimen of systemic therapy.
Patient has failed 3 regimens of chemotherapy for metastatic disease, not including adjuvant therapy.

Gender Female
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ICMJE Contact: Melissa Swank 314-747-5543 swankm@ccadmin.wustl.edu
Contact: Staci Johnson, M.Ed. 314-362-8547 johnsons@ccadmin.wustl.edu

Location Countries ICMJE United States

Administrative Information
NCT ID ICMJE NCT00355316
Responsible Party William Gillanders, MD, Washington University School of Medicine
Study ID Numbers ICMJE 05-0435
Study Sponsor ICMJE Washington University School of Medicine
Collaborators ICMJE National Institutes of Health (NIH)
Investigators ICMJE Principal Investigator: William E. Gillanders, M.D. Washington University School of Medicine

Information Provided By Washington University School of Medicine
Verification Date October 2009