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

NCT00516542 | Terminated Phase 1 DMC

• 5 other identifiers: SOL-06019-LR21CA119598P30CA069533OHSU-e2109OHSU-IRB00002109
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

letrozole DRUG

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

DHEA DRUG

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.

pharmacological study OTHER

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 \[Herceptin®\])

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Letrozole; Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 17-Ketosteroids; Ketosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones

Study Officials

• Rodney F. Pommier, MD

  Oregon Health and Science University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 15, 2007
• Study Start: June 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2010
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

US (1)