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

Not Applicable

Completed

• Conditions: Breast Neoplasms
• Interventions: Other: Blood draw

• Registration Number: NCT00355316
• Lead Sponsor: Washington University School of Medicine

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

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-07-19
• Study First Submitted QC: 2006-07-19
• Study First Posted: 2006-07-21
• Primary Completion: 2012-11
• Study Completion: 2013-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage IV Breast Cancer	Blood draw	Blood draws at baseline before systemic therapy. Blood draw then every 6 weeks for approximately 12 weeks.
Healthy Volunteers	Blood draw	Baseline blood draw.

Primary Outcome Measures

Name	Time	Method
The prevalence of breast cancer cells in the peripheral blood	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Compare molecular analyses to the results of the CellSeach assay	Approximately 12 weeks
Evaluate the prognostic significance of molecular detection of breast cancer cells in peripheral blood after initiation of systemic therapy.	Until patient death	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	Approximately 12 weeks	Determine if baseline molecular marker expression levels are dependent on patient age, race, and/or the presence of benign breast disease.

Trial Locations

Locations (2)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States