DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer

NCT00972023 | Terminated Phase 1 Results

• 3 other identifiers: CDR0000653162P30CA022453WSU-2008-012
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Dehydroepiandrosterone (DHEA) may slow the growth of tumor cells and be an effective treatment for women with breast cancer. PURPOSE: This phase I trial is studying how well DHEA works in treating women undergoing surgery for stage I, stage II, or stage III breast cancer.

Conditions

Breast Cancer

Keywords

triple-negative breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• Tumor Proliferation (Percentage of Ki-67 Positive Cells)

  Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.

Secondary Outcomes (3)

• Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression

  Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.

• Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate)

  Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.

• Toxicity

  Within 48 hours prior to surgery and after 14 days of DHEA treatment.

Study Arms (1)

DHEA, surgical resection

EXPERIMENTAL

Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;

Drug: DHEA; Procedure: Surgical resection

Interventions

DHEA DRUG

DHEA administration will begin approxiately 14 days prior to surgery.

Also known as: therapeutic dehydroepiandrosterone

DHEA, surgical resection

Surgical resection PROCEDURE

Surgical procedure of the invasive breast cancer

DHEA, surgical resection

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed invasive adenocarcinoma of the breast * Stage I (T1c), II, or III disease (AJCC staging system) * Lesion ≥ 1 cm on breast imaging studies (mammogram, ultrasound, or MRI) * HER2/neu-negative tumor * Planning to receive dehydroepiandrosterone (DHEA) prior to surgery * Disease amenable to surgery with curative intent * Scheduled to undergo surgery immediately after completion of DHEA * No locally advanced or metastatic disease not amenable to surgery * Hormone receptor status: * Estrogen receptor- and progesterone receptor-negative tumor * Androgen receptor-positive tumor PATIENT CHARACTERISTICS: * Menopausal status not specified * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * ANC ≥ 1,000/mm\^3 * Platelet count ≥ 75,000/mm\^3 * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ 2 times ULN * Hemoglobin \> 9 g/dL * Creatinine normal OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 1 week after completion of study therapy * No history of allergic reactions attributed to compounds of similar chemical or biological composition to DHEA or anastrozole * No concurrent uncontrolled illness, including but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 5 years since prior surgery, radiotherapy, biological therapy, hormone therapy, and/or chemotherapy for invasive breast cancer * No other concurrent antineoplastic or antitumor agents * No other concurrent investigational agents

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

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Dehydroepiandrosterone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Elaina Gartner
• Organization: Barbara Ann Karmanos Cancer Institute

egartner@seagen.com

800-527-6266

Study Officials

• Zeina Nahleh, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: September 3, 2009
• First Posted: September 4, 2009
• Study Start: February 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: August 22, 2010
• Last Updated: September 17, 2019
• Results First Posted: July 10, 2013

Record last verified: 2019-09

Locations

US (1)