Trial | NCT00671476  Report issue

Title

Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery
Intraductal Therapy of DCIS: A Presurgery Study

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    doxorubicin ...

  • Study Participants

    30
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.
Study Started
Feb 29
2008
Primary Completion
Feb 28
2011
Anticipated
Last Update
Jan 10
2014
Estimate

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

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
No Results Posted