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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00671476
First received: May 2, 2008
Last updated: January 9, 2014
Last verified: June 2009

May 2, 2008
January 9, 2014
February 2008
February 2011   (final data collection date for primary outcome measure)
  • Efficacy [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
  • Ability to identify and cannulate the duct [ Designated as safety issue: No ]
  • Integration of the Humboldt Community Breast Health Project into the planning and execution of this study [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00671476 on ClinicalTrials.gov Archive Site
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Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery
Intraductal Therapy of DCIS: A Presurgery Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Masking: Single Blind
Primary Purpose: Treatment
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
February 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
United States
 
NCT00671476
CDR0000594671, DSLRF-SJHCA-00003154, SJHCA-00003154
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Doctor Susan Love Research Foundation
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Principal Investigator: Susan Love, MD, MBA Doctor Susan Love Research Foundation
National Cancer Institute (NCI)
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP