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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00516542

Enrollment

Registered

2007-08-15

Start date

2007-06-30

Completion date

2010-12-31

Last updated

2012-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer, male breast cancer

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.

Interventions

DRUGletrozole

A daily dose of 2.5 mg will be used throughout the study.

DRUGDHEA

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.

OTHERpharmacological study

PK draws will happen on day 1 and day 14, then every 2 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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 \[Herceptin®\])

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026