NCT00899548

DNA in Predicting Response After Systemic Therapy in Women With Metastatic Breast Cancer

DNA Methylation in Serum as a Predictive Marker of Progression and Survival Following Systemic Therapy in Patients With Metastatic Breast Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 182 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: Studying samples of blood from patients with cancer and from healthy participants in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to systemic therapy. PURPOSE: This laboratory study is looking at DNA in predicting response after systemic therapy in women with metastatic breast cancer.

Detailed description

OBJECTIVES: Primary * Identify a panel of methylated gene markers in serum from women with metastatic breast cancer that is significantly different from that observed in healthy participants. * Assess changes in a panel of methylated gene markers from baseline, after 3-4 weeks, and after 9-12 weeks of systemic therapy in patients with metastatic breast cancer. * Determine the potential effects of common exposures (i.e., alcohol, smoking, medications, and dietary factors) on patterns of serum methylation in patients with metastatic breast cancer and in healthy participants. * Develop a predictive model using DNA methylation profiles in serum that predicts clinical outcome for an individual patient with metastatic disease. Secondary * Correlate circulating tumor cells (CTCs) with clinical outcome in patients with metastatic breast cancer. * Correlate CTCs with serum methylation in these patients. * Determine if the addition of CTCs to serum methylation results in an improved predictive model. OUTLINE: This is a prospective, multicenter study. Patients and healthy participants fill out health assessment questionnaires at baseline, week 3-4, and week 9-12. Patients undergo blood collection for methylated marker analysis at baseline, weeks 3-4, and weeks 9-12 and circulating tumor cell levels at baseline and weeks 3-4. Healthy participants undergo blood collection for methylated marker analysis at baseline. An additional cohort of healthy participants undergo follow-up blood collection ≥ 1 week after baseline. DNA methylation is measured by quantitative multiplex methylation-specific polymerase chain reaction (QM-MSP) assay. After completion of study procedures, patients are followed every 3-4 months. PROJECTED ACCRUAL: A total of 150 patients and 150 healthy participants will be accrued for this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
GENETIC	DNA methylation analysis	laboratory analysis
GENETIC	microarray analysis	laboratory analysis
GENETIC	polymerase chain reaction	laboratory analysis
OTHER	laboratory biomarker analysis	laboratory analysis

Timeline

• Start date: 2007-01-01
• Primary completion: 2010-06-01
• Completion: 2016-10-01
• First posted: 2009-05-12
• Last updated: 2019-07-26
• Results posted: 2019-07-26

Locations

4 sites across 1 country: United States