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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00899548
First received: May 9, 2009
Last updated: March 14, 2014
Last verified: March 2014

May 9, 2009
March 14, 2014
September 2006
June 2010   (final data collection date for primary outcome measure)
  • Correlation of changes in gene marker methylation with progression at 9-12 weeks [ Time Frame: 9-12 weeks ] [ Designated as safety issue: No ]
  • Changes in methylated gene markers from baseline, after 3-4 weeks, and after 9-12 weeks [ Time Frame: 9-12 weeks ] [ Designated as safety issue: No ]
  • Effects of common exposures (i.e., alcohol, smoking, medications, and dietary factors) on patterns of serum methylation [ Time Frame: 9-12 weeks ] [ Designated as safety issue: No ]
  • Creation of a predictive model of DNA methylation profiles [ Time Frame: 9-12 weeks ] [ Designated as safety issue: No ]
  • Correlation of changes in gene marker methylation with progression at 9-12 weeks [ Designated as safety issue: No ]
  • Changes in methylated gene markers from baseline, after 3-4 weeks, and after 9-12 weeks [ Designated as safety issue: No ]
  • Effects of common exposures (i.e., alcohol, smoking, medications, and dietary factors) on patterns of serum methylation [ Designated as safety issue: No ]
  • Creation of a predictive model of DNA methylation profiles [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00899548 on ClinicalTrials.gov Archive Site
  • Correlation of gene marker methlyation with survival [ Time Frame: 9-12 weeks, survival ] [ Designated as safety issue: No ]
  • Correlation of gene marker methlyation with time to progression [ Time Frame: 9-12 weeks ] [ Designated as safety issue: No ]
  • Correlation of circulating tumor cells (CTCs) with clinical outcome [ Time Frame: 3-4 weeks ] [ Designated as safety issue: No ]
  • Correlation of CTCs with serum methylation [ Time Frame: 3-4 weeks ] [ Designated as safety issue: No ]
  • Determination if the addition of CTCs to serum methylation results in an improved predictive model [ Time Frame: 3-4 weeks ] [ Designated as safety issue: No ]
  • Correlation of gene marker methlyation with survival [ Designated as safety issue: No ]
  • Correlation of gene marker methlyation with time to progression [ Designated as safety issue: No ]
  • Correlation of circulating tumor cells (CTCs) with clinical outcome [ Designated as safety issue: No ]
  • Correlation of CTCs with serum methylation [ Designated as safety issue: No ]
  • Determination if the addition of CTCs to serum methylation results in an improved predictive model [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum, plasma, DNA, RNA, whole blood

Probability Sample

Metastatic breast cancer patients and women without a history of breast cancer (ie, healthy women or "normals')

Breast Cancer
  • Genetic: DNA methylation analysis
    laboratory analysis
  • Genetic: microarray analysis
    laboratory analysis
  • Genetic: polymerase chain reaction
    laboratory analysis
  • Other: laboratory biomarker analysis
    laboratory analysis
  • Metastatic breast cancer patients
    Interventions:
    • Genetic: DNA methylation analysis
    • Genetic: microarray analysis
    • Genetic: polymerase chain reaction
    • Other: laboratory biomarker analysis
  • Normals/Controls
    Interventions:
    • Genetic: DNA methylation analysis
    • Genetic: microarray analysis
    • Genetic: polymerase chain reaction
    • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
Not Provided
June 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Histologically and/or cytologically confirmed stage IV adenocarcinoma of the breast (patient)
    • No diagnosis of an abnormal breast biopsy (including atypical ductal or lobular hyperplasia), or new diagnosis of breast cancer or breast cancer recurrence within the past five years (healthy participant)
  • Evidence of disease progression AND initiating a new systemic treatment regimen with trastuzumab (Herceptin®), chemotherapy, endocrine therapy, or investigational agent(s) (patient)

    • Treatment may be given as a single agent or in combination
  • Measurable or evaluable disease (patient)

    • Measurable disease is defined as ≥ 1 measurable lesion identified by RECIST criteria
    • Patients with evaluable disease only must have ≥ 1 tumor marker (e.g., carcinoembryonic antigen, CA 27-29, or CA 15-3) above normal level
  • Treated brain metastases (surgery or radiation therapy) allowed provided patient has evidence of disease stability or presence of other site(s) of measurable or evaluable disease (patient)

    • No leptomeningeal disease
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • ECOG performance status 0-2
  • No known cancer within the past 5 years other than basal cell or squamous cell carcinoma of the skin and/or adequately treated cervical cancer (healthy participant)
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Prior therapy in the preoperative, adjuvant, and/or metastatic setting allowed

    • Any number of prior regimens in any setting allowed
  • No prior radiation therapy to the only site of disease unless there is evidence of post-radiation disease progression
  • No selective estrogen receptor modulator or aromatase inhibitor for breast cancer prevention or therapy within the past 12 months (healthy participant)
  • Prior or concurrent use of raloxifene for osteopenia or osteoporosis therapy allowed (healthy participant)
  • Concurrent participation in another clinical trial, including one involving an investigational agent(s), allowed
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00899548
JHOC-J0524, CDR0000509417, P30CA006973, JHOC-J0524, JHOC-SKCCC-J0524
No
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Antonio C. Wolff, MD Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP