Breast CancerPhase 1NCT00788112
Vorinostat in Treating Women With Ductal Carcinoma in Situ of the Breast
A Phase 1 study testing vorinostat, protein expression analysis and immunohistochemistry staining method in people with Breast Cancer, run by University of California, San Francisco at 1 site in United States.
Trial summary
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This clinical trial is studying how well vorinostat works in treating women with ductal carcinoma in situ of the breast. 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?
- vorinostat, protein expression analysis and immunohistochemistry staining method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to 11 Aug 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 confirmed (by core biopsy) ductal carcinoma in situ
- Stage 0 disease
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-2
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Potassium and magnesium levels normal
- Prothrombin time or INR ≤ 1.5 times upper limit of normal (ULN) (unless the patient is receiving therapeutic anticoagulation)
- Partial thromboplastin time ≤ 1.2 times ULN (unless the patient is receiving therapeutic anticoagulation)
- Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective barrier methods of contraception
- No known psychiatric or substance abuse disorder that would preclude cooperation with the study requirements
- No active hepatitis A, B, or C infection
- No active HIV infection
- No other active infection
- No other malignancy within the past 5 years
- No condition that would interfere with the absorption or intake of vorinostat
- No history or current evidence of any condition or laboratory abnormality that would confound study results, interfere with the patient's participation in the full duration of the study, or that would not be in the best interest of the patient to participate
PRIOR CONCURRENT THERAPY:
- More than 2 weeks since prior IV antibiotics, antivirals, or antifungals
- No prior gastrointestinal surgery or other procedure that would interfere with the absorption or intake of vorinostat
- No prior or concurrent therapy with any other HDAC inhibitor, including valproic acid
- No prior treatment with any other investigational agent
- No concurrent systemic steroids
- No concurrent anticancer chemotherapy, radiotherapy, biological therapy, or other investigational therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This clinical trial is studying how well vorinostat works in treating women with ductal carcinoma in situ of the breast.
Read the detailed description
OBJECTIVES:
- To evaluate the in vivo molecular and biological effects of vorinostat by analyzing changes in proliferation and apoptosis, histone acetylation, and HDAC protein expression in women with ductal carcinoma in situ of the breast.
OUTLINE: Patients receive oral vorinostat twice a day for 3 days in the absence of unacceptable toxicity. Patients then undergo lumpectomy or mastectomy 2 hours after the last dose of vorinostat.
Blood and tissue samples are collected at baseline and during surgery for biomarker laboratory studies. Samples are analyzed by immunohistochemistry for Ki-67, HDAC1 and HDAC6 protein expression, and histone H4 and α-tubulin acetylation.
After completion of study therapy, patients are followed for 1 month and then every 6 months for 5 years.
- Conditions
- Breast Cancer
- Being tested
- vorinostat, protein expression analysis, immunohistochemistry staining method, laboratory biomarker analysis, neoadjuvant therapy
- Keywords
- ductal breast carcinoma in situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vorinostatDrug
protein expression analysisGenetic
laboratory biomarker analysisOther
neoadjuvant therapyProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Vorinostat | Experimental | Not described Receives: Drug: vorinostat; Genetic: protein expression analysis; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: neoadjuvant therapy; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Ki-67 compared to baseline Ki-67
Measured: 3 days prior to surgery
Secondary outcomes (1)
Changes in HDAC1 and HDAC6 expression and histone H4 and α-tubulin acetylation in breast tissue and serum samples
Measured: 3 days prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2008 (estimated)
- Study startJul 2009
- Primary completion3 Nov 2011
- Study completion11 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Laura Esserman, MD, MBA, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788112
- Sponsor's protocol ID
- CDR0000617655
- Other IDs
- UCSF-077532, H10367-31833, UCSF-07031833
- Status last verified
- Aug 2017
- First submitted
- 7 Nov 2008
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Window Trial of Vorinostat in Patients With Ductal Carcinoma in Situ (DCIS) of the Breast
- ClinicalTrials.gov ID
- NCT00788112
- Acronym / sponsor ID
- CDR0000617655
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma in situ
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2009
- Primary completion
- 3 Nov 2011 (actual)
- Study completion
- 11 Aug 2015 (actual)
- First posted
- 10 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This clinical trial is studying how well vorinostat works in treating women with ductal carcinoma in situ of the breast.
Detailed description
OBJECTIVES:
- To evaluate the in vivo molecular and biological effects of vorinostat by analyzing changes in proliferation and apoptosis, histone acetylation, and HDAC protein expression in women with ductal carcinoma in situ of the breast.
OUTLINE: Patients receive oral vorinostat twice a day for 3 days in the absence of unacceptable toxicity. Patients then undergo lumpectomy or mastectomy 2 hours after the last dose of vorinostat.
Blood and tissue samples are collected at baseline and during surgery for biomarker laboratory studies. Samples are analyzed by immunohistochemistry for Ki-67, HDAC1 and HDAC6 protein expression, and histone H4 and α-tubulin acetylation.
After completion of study therapy, patients are followed for 1 month and then every 6 months for 5 years.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vorinostat | Experimental | Drug: vorinostat, Genetic: protein expression analysis, Other: immunohistochemistry staining method, Other: laboratory biomarker analysis, Procedure: neoadjuvant therapy, Procedure: therapeutic conventional 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 |
|---|---|---|
| vorinostat | Drug | Vorinostat |
| protein expression analysis | Genetic | Vorinostat |
| immunohistochemistry staining method | Other | Vorinostat |
| laboratory biomarker analysis | Other | Vorinostat |
| neoadjuvant therapy | Procedure or surgery | Vorinostat |
| therapeutic conventional surgery | Procedure or surgery | Vorinostat |
Primary outcome
Reduction in Ki-67 compared to baseline Ki-67
Time frame: 3 days prior to surgery
1 secondary outcome
Changes in HDAC1 and HDAC6 expression and histone H4 and α-tubulin acetylation in breast tissue and serum samples
Time frame: 3 days prior to surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
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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.
Laura Esserman, MD, MBA principal investigator
University of California, San Francisco
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 vorinostat, protein expression analysis and immunohistochemistry staining method in people with Breast Cancer, run by University of California, San Francisco 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: finished, as of the sponsor's last update on 7 Aug 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in Ki-67 compared to baseline Ki-67 (time frame: 3 days prior to surgery). 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 7 Aug 2017.