Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery
Recruitment status was: Recruiting
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.
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 Design:||Allocation: Randomized
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Intraductal Therapy of DCIS: A Presurgery Study|
- 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 ]
|Study Start Date:||February 2008|
|Estimated Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00671476
|United States, California|
|St. Joseph Hospital|
|Eureka, California, United States, 95501|
|Doctor Susan Love Research Foundation|
|Santa Monica, California, United States, 90403|
|Principal Investigator:||Susan Love, MD, MBA||Dr. Susan Love Research Foundation|