NCT00671476

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This clinical trial is studying the side effects of doxorubicin hydrochloride liposome and to see how well it works in treating women with ductal carcinoma in situ undergoing surgery.

Trial Health

55
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Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Last Updated

January 10, 2014

Status Verified

June 1, 2009

Enrollment Period

3 years

First QC Date

May 2, 2008

Last Update Submit

January 9, 2014

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ

Outcome Measures

Primary Outcomes (4)

  • Efficacy

  • Safety

  • Ability to identify and cannulate the duct

  • Integration of the Humboldt Community Breast Health Project into the planning and execution of this study

Interventions

pegylated liposomal doxorubicin hydrochlorideDRUG
DNA methylation analysisGENETIC
TdT-mediated dUTP nick end labeling assayGENETIC
fluorescence in situ hybridizationGENETIC
loss of heterozygosity analysisGENETIC
polymerase chain reactionGENETIC
immunoenzyme techniqueOTHER
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER
breast duct lavagePROCEDURE
neoadjuvant therapyPROCEDURE
therapeutic conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of ductal breast carcinoma in situ by core needle biopsy * No pathological invasive or microinvasive disease in the affected breast * Mammographic microcalcifications are limited to one ductal system or one quadrant of breast * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Must be able to undergo necessary surgery * Not pregnant PRIOR CONCURRENT THERAPY: * No prior surgery or radiotherapy to the recently diagnosed breast * More than 12 months since prior chemotherapy * No prior subareolar breast surgery to the affected breast * Not concurrently involved in a research protocol for unapproved new drug evaluation

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

Sponsors & Collaborators

Study Sites (2)

St. Joseph Hospital

Eureka, California, 95501, United States

RECRUITING

Doctor Susan Love Research Foundation

Santa Monica, California, 90403, United States

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Interventions

DNA MethylationIn Situ Hybridization, FluorescencePolymerase Chain ReactionImmunoenzyme TechniquesImmunohistochemistryNeoadjuvant 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)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaIn Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationNucleic Acid Amplification TechniquesImmunoassayImmunologic TechniquesMolecular Probe TechniquesHistocytochemistryCombined Modality TherapyTherapeutics

Study Officials

  • Susan Love, MD, MBA

    Dr. Susan Love Research Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2008

First Posted

May 5, 2008

Study Start

February 1, 2008

Primary Completion

February 1, 2011

Last Updated

January 10, 2014

Record last verified: 2009-06

Locations

US(2)