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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00516542
• Other study ID #: SOL-06019-L
• Secondary ID: R21CA119598P30CA
• Status: Terminated
• Phase: Phase 1
• First received: August 14, 2007
• Last updated: July 23, 2012
• Start date: June 2007
• Est. completion date: December 2010

Study information

• Verified date: July 2012
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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®])

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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.

Other:
• pharmacological study
PK draws will happen on day 1 and day 14, then every 2 weeks.

Locations

Country	Name	City	State
United States	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes