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

This study has been terminated.

(Study was terminated due to lack of accrual)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

OHSU Knight Cancer Institute

ClinicalTrials.gov Identifier:

NCT00516542

First received: August 14, 2007

Last updated: July 23, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 14, 2007

Last Updated Date

July 23, 2012

Start Date ^ICMJE

June 2007

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Dose-limiting toxicity [ Time Frame: One year from drug start ] [ Designated as safety issue: Yes ]

Subjects will be monitored at day 14 and then every 2 weeks for up to one year.

Original Primary Outcome Measures ^ICMJE

Dose-limiting toxicity
Maximum tolerable dose
Pharmacokinetics

Change History

Complete list of historical versions of study NCT00516542 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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®])

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00516542

Other Study ID Numbers ^ICMJE

SOL-06019-L, R21CA119598, P30CA069533, OHSU-e2109, OHSU-IRB00002109

Has Data Monitoring Committee

Yes

Responsible Party

OHSU Knight Cancer Institute

Study Sponsor ^ICMJE

OHSU Knight Cancer Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Rodney F. Pommier, MD

Oregon Health and Science University

Information Provided By

OHSU Knight Cancer Institute

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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