Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Blood Sample Collection and Health Information Collection from Patients With Invasive Breast Cancer and Their Brothers and Sisters
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Natural history/Epidemiology, Tissue collection/Repository | Active | 18 and over | Pharmaceutical / Industry | GENBASIX-00127 GENBASIX-1024122, NCT00445562 |
Objectives
- Collect blood samples and medical and background information from patients with invasive breast cancer and their affected or unaffected siblings.
Entry Criteria
Disease Characteristics:
- Meets 1 of the following criteria:
- Pathologically confirmed invasive breast cancer (patient)
- No ductal carcinoma in situ
- Affected OR unaffected sibling
- Affected sibling must have had (or currently has) breast cancer only
- Unaffected sibling must be female
- No deceased siblings
- Must be a full-blood related sibling
- Pathologically confirmed invasive breast cancer (patient)
- Patients receiving treatment on clinical trial ECOG-E1Y97 or ECOG-E3Y92 are not eligible
Prior/Concurrent Therapy:
- Not specified
Patient Characteristics:
- Not specified
Expected Enrollment
1000A total of 1,000 patients and siblings will be accrued for this study.
Outcomes
Primary Outcome(s)Collection of blood samples and medical and background information
Outline
Patients and their siblings undergo blood collection. They also complete medical and background questionnaires.
Patients and their siblings are followed annually for 5 years.
Trial Lead Organizations
GenBasix Incorporated
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| Richard Shapiro, MD, Protocol chair | |
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| U.S.A. | |||||||
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| California | |||||||
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| Duarte | |||||||
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| GenBasix Incorporated | |||||||
| Richard Shapiro, MD |
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Related Information
PDQ® clinical trial CDR0000066283
| Registry Information | ||
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| Official Title | Breast Cancer Siblings Database | |
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| Trial Start Date | 2001-01-03 | |
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| Trial Completion Date | 2004-12-07 | |
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| Registered in ClinicalTrials.gov | NCT00445562 | |
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| Date Submitted to PDQ | 2007-01-03 | |
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| Information Last Verified | 2009-07-05 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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