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Trial record 4 of 12 for:    "Breast Ductal Carcinoma" | "Topoisomerase Inhibitors"

Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00671476
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : May 5, 2008
Last Update Posted : January 10, 2014
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: pegylated liposomal doxorubicin hydrochloride Genetic: DNA methylation analysis Genetic: TdT-mediated dUTP nick end labeling assay Genetic: fluorescence in situ hybridization Genetic: loss of heterozygosity analysis Genetic: polymerase chain reaction Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: breast duct lavage Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Not Applicable

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Masking: Single
Primary Purpose: Treatment
Official Title: Intraductal Therapy of DCIS: A Presurgery Study
Study Start Date : February 2008
Estimated Primary Completion Date : February 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Efficacy
  2. Safety
  3. Ability to identify and cannulate the duct
  4. Integration of the Humboldt Community Breast Health Project into the planning and execution of this study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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


  • Menopausal status not specified
  • Must be able to undergo necessary surgery
  • Not pregnant


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00671476

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United States, California
St. Joseph Hospital Recruiting
Eureka, California, United States, 95501
Contact: M. Ellen Mahoney, MD    707-445-8121      
Doctor Susan Love Research Foundation Recruiting
Santa Monica, California, United States, 90403
Contact: Susan Love, MD, MBA    866-569-0388   
Sponsors and Collaborators
Dr. Susan Love Research Foundation
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Principal Investigator: Susan Love, MD, MBA Dr. Susan Love Research Foundation

Layout table for additonal information Identifier: NCT00671476     History of Changes
Other Study ID Numbers: CDR0000594671
First Posted: May 5, 2008    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: June 2009
Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ
Additional relevant MeSH terms:
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Topoisomerase Inhibitors
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action