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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355316
• Other study ID #: 05-0435 / 201109033
• Status: Completed
• Phase: N/A
• First received: July 19, 2006
• Last updated: June 19, 2013
• Start date: November 2005
• Est. completion date: February 2013

Study information

• Verified date: June 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• Blood draw

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

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* Note: There are 80 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluate the prognostic significance of molecular detection of breast cancer cells in peripheral blood after initiation of systemic therapy.	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.	Until patient death	No
Secondary	Quantify baseline molecular marker expression levels in the peripheral blood of healthy volunteers	Determine if baseline molecular marker expression levels are dependent on patient age, race, and/or the presence of benign breast disease.	Approximately 12 weeks	No
Secondary	Compare molecular analyses to the results of the CellSeach assay		Approximately 12 weeks	No

External Links

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