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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00671476
First Posted: May 5, 2008
Last Update Posted: January 10, 2014
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.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single
Primary Purpose: Treatment
Official Title: Intraductal Therapy of DCIS: A Presurgery Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: February 2008
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00671476


Locations
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    info@dslrf.org   
Sponsors and Collaborators
Dr. Susan Love Research Foundation
Investigators
Principal Investigator: Susan Love, MD, MBA Dr. Susan Love Research Foundation
  More Information

ClinicalTrials.gov Identifier: NCT00671476     History of Changes
Other Study ID Numbers: CDR0000594671
DSLRF-SJHCA-00003154
SJHCA-00003154
First Submitted: May 2, 2008
First Posted: May 5, 2008
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:
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action