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

Primary Purpose

Breast Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

letrozole

DHEA

pharmacological study

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer, male breast cancer

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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®])

Sites / Locations

Knight Cancer Institute at Oregon Health and Science University

Outcomes

Primary Outcome Measures

Dose-limiting toxicity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00516542

First Posted

August 14, 2007

Last Updated

July 23, 2012

Sponsor

OHSU Knight Cancer Institute

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00516542

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated due to lack of accrual

Study Start Date

June 2007 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

OHSU Knight Cancer Institute

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

letrozole

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

DHEA

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

pharmacological study

Intervention Description

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

Primary Outcome Measure Information:

Title

Dose-limiting toxicity

Description

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

Time Frame

One year from drug start

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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®])

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rodney F. Pommier, MD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Study Chair

Facility Information:

Facility Name

Knight Cancer Institute at Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239-3098

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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