Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Androgens can cause the growth of breast cancer cells. Hormone therapy using dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the tumor cells. Letrozole may stop the adrenal glands from making androgens. Giving DHEA together with letrozole may kill more tumor cells. 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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OBJECTIVES: 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.

Official Title
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A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: letrozole
* Drug: DHEA
* Other: pharmacological study


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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®])

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: letrozole|A daily dose of 2.5 mg will be used throughout the study.|
|Drug: 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.|
|Other: pharmacological study|PK draws will happen on day 1 and day 14, then every 2 weeks.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicity | Subjects will be monitored at day 14 and then every 2 weeks for up to one year. | One year from drug start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer, male breast cancer