Clinical trial · Interventional
DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
A Pilot Study of Androgen Receptor as a Target for the Treatment of ER-/PR-/AR + Breast Cancer
NCT00972023CI-TRIAL-00040639terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DHEA | Drug | — | UNRESOLVED |
| Surgical resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DHEA, surgical resection
- 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;
- interventionNames
- Drug: DHEA
- Procedure: Surgical resection
Primary outcomes (1)
- measure
- Tumor Proliferation (Percentage of Ki-67 Positive Cells)
- timeFrame
- Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
Secondary outcomes (3)
- measure
- Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression
- timeFrame
- Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.