Status:
COMPLETED
DNA in Predicting Response After Systemic Therapy in Women With Metastatic Breast Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief 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 r...
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. * Asse...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT00899548
Start Date
January 1 2007
End Date
October 1 2016
Last Update
July 26 2019
Active Locations (4)
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1
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
3
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
4
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295