Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00972023
Recruitment Status : Terminated
First Posted : September 4, 2009
Results First Posted : July 10, 2013
Last Update Posted : March 21, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Ann Karmanos Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: DHEA
Procedure: Surgical resection
Enrollment 1
Recruitment Details Cancer center clinic
Pre-assignment Details  
Arm/Group Title DHEA, Surgical Resection
Hide Arm/Group Description

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

Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title DHEA, Surgical Resection
Hide Arm/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;

DHEA : DHEA administration will begin approxiately 14 days prior to surgery.

Surgical resection : Surgical procedure of the invasive breast cancer

Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
52  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Tumor Proliferation (Percentage of Ki-67 Positive Cells)
Hide Description [Not Specified]
Time Frame Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.
Arm/Group Title DHEA, Surgical Resection
Hide Arm/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;

DHEA : DHEA administration will begin approxiately 14 days prior to surgery.

Surgical resection : Surgical procedure of the invasive breast cancer

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression
Hide Description [Not Specified]
Time Frame Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.
Arm/Group Title DHEA, Surgical Resection
Hide Arm/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;

DHEA: DHEA administration will begin approxiately 14 days prior to surgery.

Surgical resection: Surgical procedure of the invasive breast cancer

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Effect of DHEA on Changes in Serum Estrogen and Androgen Hormone Levels (e.g., Estrone, Estradiol, Testosterone, Dihydrotestosterone, DHEA, and DHEA-sulfate)
Hide Description [Not Specified]
Time Frame Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.
Arm/Group Title DHEA, Surgical Resection
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Toxicity
Hide Description [Not Specified]
Time Frame Within 48 hours prior to surgery and after 14 days of DHEA treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, although no analysis was completed, patient chose to receive neoadjuvant chemo instead of surgery & refused follow up.
Arm/Group Title DHEA, Surgical Resection
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DHEA, Surgical Resection
Hide Arm/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;

DHEA : DHEA administration will begin approxiately 14 days prior to surgery.

Surgical resection : Surgical procedure of the invasive breast cancer

All-Cause Mortality
DHEA, Surgical Resection
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DHEA, Surgical Resection
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DHEA, Surgical Resection
Affected / at Risk (%)
Total   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Elaina Gartner
Organization: Barbara Ann Karmanos Cancer Institute
Phone: 800-527-6266
Responsible Party: Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00972023     History of Changes
Other Study ID Numbers: CDR0000653162
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2008-012
First Submitted: September 3, 2009
First Posted: September 4, 2009
Results First Submitted: April 23, 2013
Results First Posted: July 10, 2013
Last Update Posted: March 21, 2017