NCT00788112

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1 breast-cancer

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 10, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2011

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2015

Completed
Last Updated

August 7, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

November 7, 2008

Last Update Submit

August 4, 2017

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ

Outcome Measures

Primary Outcomes (1)

  • Reduction in Ki-67 compared to baseline Ki-67

    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

    3 days prior to surgery

Study Arms (1)

Vorinostat

EXPERIMENTAL
Drug: vorinostatGenetic: protein expression analysisOther: immunohistochemistry staining methodOther: laboratory biomarker analysisProcedure: neoadjuvant therapyProcedure: therapeutic conventional surgery

Interventions

vorinostatDRUG
Vorinostat
protein expression analysisGENETIC
Vorinostat
immunohistochemistry staining methodOTHER
Vorinostat
laboratory biomarker analysisOTHER
Vorinostat
neoadjuvant therapyPROCEDURE
Vorinostat
therapeutic conventional surgeryPROCEDURE
Vorinostat

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Interventions

VorinostatImmunohistochemistryNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic AcidsHistocytochemistryCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesImmunologic TechniquesCombined Modality TherapyTherapeutics

Study Officials

  • Laura Esserman, MD, MBA

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2008

First Posted

November 10, 2008

Study Start

July 1, 2009

Primary Completion

November 3, 2011

Study Completion

August 11, 2015

Last Updated

August 7, 2017

Record last verified: 2017-08

Locations

US(1)