Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer
NCT ID: NCT00516542
Last Updated: 2012-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
6 participants
INTERVENTIONAL
2007-06-30
2010-12-31
Brief Summary
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PURPOSE: This phase I trial is studying the side effects and best dose of DHEA when given together with letrozole in treating patients with metastatic breast cancer.
Detailed Description
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* To determine the maximum tolerable dose, dose-limiting toxicity, and pharmacokinetics of dehydroepiandrosterone (DHEA) when given together with letrozole in patients with androgen receptor-positive and estrogen receptor- and progesterone receptor-negative metastatic breast cancer.
OUTLINE: Patients receive oral dehydroepiandrosterone and oral letrozole once daily. Physical exams and blood collections are performed every two weeks. Tumor assessments are performed once every three months.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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letrozole
A daily dose of 2.5 mg will be used throughout the study.
DHEA
Will be dispensed in either 500mg or 1000mg tablets. Subjects will start at a dose of 500 mg and may increase up to 5000mg depending on the cohort.
pharmacological study
PK draws will happen on day 1 and day 14, then every 2 weeks.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of breast cancer
* Metastatic disease
* Hormone receptor status
* Estrogen receptor- and progesterone receptor-negative
* Androgen receptor-positive
PATIENT CHARACTERISTICS:
* ECOG performance status 0-3
* Postmenopausal (\> 60 years of age)
* Leukocyte count \> 3,000/uL
* Absolute neutrophil count \> 1,500/uL
* Platelet count \> 100,000/uL
* Total bilirubin normal
* AST and ALT \< 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance \> 60 mL/min
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since prior chemotherapy
* At least 4 weeks since prior biologic therapy
* At least 4 weeks since prior radiotherapy
* At least 30 days since prior investigational agents
* No concurrent dehydroepiandrosterone or androstenedione supplements
* No concurrent chemotherapy or radiotherapy
* No concurrent hormone therapy or immunotherapy (including trastuzumab \[Herceptin®\])
60 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Rodney F. Pommier, MD
Role: STUDY_CHAIR
Oregon Health and Science University
Locations
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Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Countries
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Other Identifiers
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OHSU-e2109
Identifier Type: -
Identifier Source: secondary_id
OHSU-IRB00002109
Identifier Type: -
Identifier Source: secondary_id
SOL-06019-L
Identifier Type: -
Identifier Source: org_study_id