A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- OHSU Knight Cancer Institute
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Dose-limiting toxicity
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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®])
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Dose-limiting toxicity
Time Frame: One year from drug start
Subjects will be monitored at day 14 and then every 2 weeks for up to one year.
Secondary Outcomes
No secondary outcomes reported