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NCT00352872 · ClinicalTrials.gov registry record
Pharmacogenetics as a Predictor of Toxicity in Pre-Menopausal Women Receiving Doxorubicin and Cyclophosphamide in Early Breast Cancer
A clinical trial, sponsored by Indiana University.
- Terminated
- Registry status
- 23
- Enrollment target
NCT00352872 is a clinical trial that was terminated before completion, run by Indiana University. The registered enrollment target is 23 participants.
The verdict
NCT00352872 was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- 23 participants
- Enrollment target
Study Summary
The goal of this pilot study is to delineate the role of genetic variations in premature menopause, hot flashes, and other toxicities in a cohort of premenopausal women with early breast cancer. Primary Objective- To ascertain the effect of common variant alleles of CYP450 2B6, 2C19, 2C9, and 3A5 in pre-menopausal women with breast cancer receiving anthracycline and cyclophosphamide based chemotherapy as it relates to occurrence of premature menopause (defined as more than 12 months of amenorrhea and serum estradiol and FSH levels consistent with post-menopausal status) Secondary Objective #1- To obtain pilot data on the effect of common variant alleles of CYP450 2B6, 2C19, 2C9, and 3A5 in pre-menopausal women with breast cancer receiving anthracycline and cyclophosphamide based chemotherapy as it relates to occurrence of hot flash frequency, and other common toxicities of therapy requiring dose delay or reduction. Secondary Objective #2- To obtain pilot data on the correlation of hot flashes with serum levels of serotonin, tryptophan, and their metabolites and with polymorphisms of the serotonin transporter and receptor genes.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2005-02 |
| Est. Completion | 2009-01-13 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00352872
The ClinicalTrials.gov registry entry for NCT00352872 describes a study currently listed as terminated, categorized as an unspecified phase. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00352872 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00352872 about?
NCT00352872 is a clinical study titled "Pharmacogenetics as a Predictor of Toxicity in Pre-Menopausal Women Receiving Doxorubicin and Cyclophosphamide in Early Breast Cancer". The goal of this pilot study is to delineate the role of genetic variations in premature menopause, hot flashes, and other toxicities in a cohort of premenopausal women with early breast cancer. Primary Objective- To ascertain the effect of common variant alleles of CYP450 2B6, 2C19, 2C9, and 3A5 i...
What is the current status of trial NCT00352872?
This trial is currently terminated. The enrollment target is 23 participants. The study started on 2005-02. Estimated completion is 2009-01-13.
Who is sponsoring clinical trial NCT00352872?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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