A Phase 1 interventional study of DHEA and Surgical resection in Breast Cancer, sponsored by Barbara Ann Karmanos Cancer Institute. Terminated at 1 site in United States. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by Barbara Ann Karmanos Cancer Institute · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 1 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Barbara Ann Karmanos Cancer Institute is the lead sponsor of 158 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed invasive adenocarcinoma of the breast
Stage I (T1c), II, or III disease (AJCC staging system)
Disease amenable to surgery with curative intent
Hormone receptor status:
PATIENT CHARACTERISTICS:
No concurrent uncontrolled illness, including but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
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
DHEA administration will begin approxiately 14 days prior to surgery.
Also known as: therapeutic dehydroepiandrosterone
Surgical procedure of the invasive breast cancer
Tumor Proliferation (Percentage of Ki-67 Positive Cells)
Time frame: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression
Time frame: 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)
Time frame: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
Toxicity
Time frame: Within 48 hours prior to surgery and after 14 days of DHEA treatment.
Cancer center clinic
| Milestone | DHEA, Surgical Resection |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DHEA, Surgical Resection | — | 0/1 (0%) | 0/1 (0%) |
| Age, Continuous(years) | DHEA, Surgical Resection |
|---|---|
| Mean | 52 ± 0 |
| Sex: Female, Male(Participants) | DHEA, Surgical Resection |
|---|---|
| Female | 1 |
| Male | 0 |
| Region of Enrollment(participants) | DHEA, Surgical Resection |
|---|---|
| United States | 1 |
This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Barbara Ann Karmanos Cancer Institute