Breast CancerPhase 1NCT00972023
DHEA in Treating Women Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
A Phase 1 study testing DHEA and Surgical resection in people with Breast Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- DHEA and Surgical resection
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to 22 Aug 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
About this study
Official title: A Pilot Study of Androgen Receptor as a Target for the Treatment of ER-/PR-/AR + Breast Cancer
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.
Read the detailed 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.
- Conditions
- Breast Cancer
- Being tested
- DHEA, Surgical resection
- Keywords
- triple-negative breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHEADrug
Also called therapeutic dehydroepiandrosterone
DHEA administration will begin approxiately 14 days prior to surgery.
Surgical resectionProcedure or surgery
Surgical procedure of the invasive breast cancer
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: Drug: DHEA; Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Proliferation (Percentage of Ki-67 Positive Cells)
Measured: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
Secondary outcomes (3)
Effect of Dehydroepiandrosterone (DHEA) on Androgen Receptor Expression
Measured: 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)
Measured: Baseline, prior to DHEA treatment, within 48 hours prior to surgery and after 14 days of DHEA treatment.
Toxicity
Measured: Within 48 hours prior to surgery and after 14 days of DHEA treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completion22 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Zeina Nahleh, MD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972023
- Sponsor's protocol ID
- CDR0000653162
- Other IDs
- P30CA022453, WSU-2008-012
- Status last verified
- Sep 2019
- First submitted
- 3 Sep 2009
- Last updated
- 17 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Androgen Receptor as a Target for the Treatment of ER-/PR-/AR + Breast Cancer
- ClinicalTrials.gov ID
- NCT00972023
- Acronym / sponsor ID
- CDR0000653162
- Conditions
- Breast Cancer
- Keywords
- triple-negative breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- 22 Aug 2010 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Posted 10 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DHEA, surgical resection | Experimental | Drug: DHEA, Procedure: Surgical resectionDay-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; |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHEAAlso: therapeutic dehydroepiandrosteroneDHEA administration will begin approxiately 14 days prior to surgery. | Drug | DHEA, surgical resection |
| Surgical resectionSurgical procedure of the invasive breast cancer | Procedure or surgery | DHEA, surgical resection |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeina Nahleh, MD principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DHEA and Surgical resection in people with Breast Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2019.