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

NCT00355316 | Completed

• 1 other identifier: 05-0435 / 201109033
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Neoplasms

Keywords

Breast Cancer; Peripheral; Blood

Outcome Measures

Primary Outcomes (1)

• The prevalence of breast cancer cells in the peripheral blood

  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.

  1 year

Secondary Outcomes (3)

• Evaluate the prognostic significance of molecular detection of breast cancer cells in peripheral blood after initiation of systemic therapy.

  Until patient death

• Quantify baseline molecular marker expression levels in the peripheral blood of healthy volunteers

  Approximately 12 weeks

• Compare molecular analyses to the results of the CellSeach assay

  Approximately 12 weeks

Study Arms (2)

Stage IV Breast Cancer

EXPERIMENTAL

Blood draws at baseline before systemic therapy. Blood draw then every 6 weeks for approximately 12 weeks.

Other: Blood draw

Healthy Volunteers

OTHER

Baseline blood draw.

Other: Blood draw

Interventions

Blood draw OTHER

Healthy Volunteers; Stage IV Breast Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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).
• 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.
• 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).

You may not qualify if:

• No documented metastatic disease.
• No measurable lesions.
• Bone only and/or brain metastasis.
• Patient is not initiating a new regimen of systemic therapy.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

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Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• William E. Gillanders, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 21, 2006
• Study Start: November 1, 2005
• Primary Completion: November 1, 2012
• Study Completion: February 1, 2013
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

US (2)