Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery
NCT ID: NCT00671476
Last Updated: 2014-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2008-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer
NCT00290732
Pegylated Liposomal Doxorubicin and Docetaxel in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery
NCT00524459
Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
NCT00006825
Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer
NCT02315196
Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery
NCT00424203
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* To demonstrate the efficacy and safety of neoadjuvant intraductal pegylated liposomal doxorubicin hydrochloride in women with ductal breast carcinoma in situ undergoing surgery.
* To demonstrate the ability to identify and cannulate the duct demonstrating precancerous disease in these women.
* To integrate the Humboldt Community Breast Health Project into the planning and execution of this study.
OUTLINE: Patients undergo identification of the intraductal lesions via cannulization. Patients receive pegylated liposomal doxorubicin hydrochloride (PLD) intraductally through the inserted cannula. Some patients are randomized to receive saline instead of PLD. Within 4-6 weeks, all patients undergo surgery.
Patients undergo tissue and ductal fluid sample collection at baseline and at surgery for correlative laboratory studies. Tissue samples are assessed for histomorphology, proliferation (Ki67), cell death (apoptosis index), genetic markers, necrosis, inflammation, and loss of heterozygosity by HE stain, IHC, TUNEL, and PCR. Nipple aspirate and ductal lavage fluid samples are analyzed for cytomorphology (cellular atypia), proliferation (Ki67), cell death (TUNEL), differentiation (G-actin), and genetic markers (FISH) by quantitative fluorescence image analysis. Samples are also analyzed for bFGF and CEA by ELISA, and methylation by PCR.
After completion of study therapy, patients are followed every 6 months for at least 2 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
SINGLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
pegylated liposomal doxorubicin hydrochloride
DNA methylation analysis
TdT-mediated dUTP nick end labeling assay
fluorescence in situ hybridization
loss of heterozygosity analysis
polymerase chain reaction
immunoenzyme technique
immunohistochemistry staining method
laboratory biomarker analysis
breast duct lavage
neoadjuvant therapy
therapeutic conventional surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dr. Susan Love Research Foundation
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Susan Love, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Dr. Susan Love Research Foundation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Joseph Hospital
Eureka, California, United States
Doctor Susan Love Research Foundation
Santa Monica, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
M. Ellen Mahoney, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DSLRF-SJHCA-00003154
Identifier Type: -
Identifier Source: secondary_id
SJHCA-00003154
Identifier Type: -
Identifier Source: secondary_id
CDR0000594671
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.