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

B

Barbara Ann Karmanos Cancer Institute

Status and phase

Terminated
Phase 1

Conditions

Breast Cancer

Treatments

Drug: DHEA
Procedure: Surgical resection

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00972023
CDR0000653162
P30CA022453 (U.S. NIH Grant/Contract)
WSU-2008-012

Details and patient eligibility

About

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.

Full description

OBJECTIVES: Primary To identify the effect of the adrenal steroid, dehydroepiandrosterone (DHEA), on tumor proliferation in women with estrogen receptor-negative, progesterone receptor-negative, HER2/neu-negative, and androgen receptor (AR)-positive stage I-III adenocarcinoma of the breast. Secondary To study the effect of DHEA on expression of AR in these patients. To assess the effect of DHEA on changes in serum estrogen and androgen hormone levels (e.g., estrone, estradiol, testosterone, dihydrotestosterone, DHEA, and DHEA-sulfate) in these patients. To assess the toxicity of DHEA in these patients. To follow the clinical course of these patients. OUTLINE: Patients receive oral dehydroepiandrosterone (DHEA) twice daily on days -14 to 0. Patients then undergo surgery on day 1. Tissue samples are collected at baseline and at the time of surgery for biomarker analysis (androgen receptor, estrogen receptor, progesterone receptor, HER2/neu, Ki-67, and p53) by IHC. Blood samples are collected at baseline and after completion of treatment with DHEA for analysis of serum hormone (e.g., estrone, estradiol, testosterone, dihydrotestosterone, DHEA, and DHEA-sulfate) and cytokine levels. After completion of study therapy, patients are followed up at 1 week and then every 6 months for 3 years.

Enrollment

1 patient

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1 participants in 1 patient group

DHEA, surgical resection
Experimental group
Description:
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;
Treatment:
Procedure: Surgical resection
Drug: DHEA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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