An interventional study of pegylated liposomal doxorubicin hydrochloride and DNA methylation analysis in Breast Cancer, sponsored by Dr. Susan Love Research Foundation. Status unknown at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-10.
Sponsored by Dr. Susan Love Research Foundation · Not applicable, Interventional, and Treatment
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:
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.
363 studies on the registry are indexed under Carcinoma in Situ; 47 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 272 interventional studies indexed under Carcinoma in Situ.
Browse Carcinoma in Situ studies →Dr. Susan Love Research Foundation is the lead sponsor of 2 studies on the registry; none are open to participants now.
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DISEASE CHARACTERISTICS:
Diagnosis of ductal breast carcinoma in situ by core needle biopsy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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
This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Dr. Susan Love Research Foundation