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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-2008-012 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHEA | Drug | DHEA administration will begin approxiately 14 days prior to surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed invasive adenocarcinoma of the breast
Stage I (T1c), II, or III disease (AJCC staging system)
HER2/neu-negative tumor
Planning to receive dehydroepiandrosterone (DHEA) prior to surgery
Disease amenable to surgery with curative intent
No locally advanced or metastatic disease not amenable to surgery
Hormone receptor status:
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Zeina Nahleh, MD | Barbara Ann Karmanos Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-1379 | United States |
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| Label | URL |
|---|---|
| Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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Cancer center clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | DHEA, Surgical Resection | DHEA, surgical resection: 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; DHEA: Administration will begin approxiately 14 days prior to surgery. Surgical resection: Surgical procedure of the invasive breast cancer |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DHEA, Surgical Resection | 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; DHEA : DHEA administration will begin approxiately 14 days prior to surgery. Surgical resection : Surgical procedure of the invasive breast cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Proliferation (Percentage of Ki-67 Positive Cells) | Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up. | Posted | Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DHEA, Surgical Resection | 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; DHEA : DHEA administration will begin approxiately 14 days prior to surgery. Surgical resection : Surgical procedure of the invasive breast cancer |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elaina Gartner | Barbara Ann Karmanos Cancer Institute | 800-527-6266 | egartner@seagen.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003687 | Dehydroepiandrosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Surgical resection | Procedure | Surgical procedure of the invasive breast cancer |
|
| 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Secondary | Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression | Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up. | Posted | Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment. |
|
|
| Secondary | Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate) | Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up. | Posted | Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment. |
|
|
| Secondary | Toxicity | Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up. | Posted | Within 48 hours prior to surgery and after 14 days of DHEA treatment. |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015068 | 17-Ketosteroids |
| D007664 | Ketosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |