Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery
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|ClinicalTrials.gov Identifier: NCT00671476|
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 5, 2008
Last Update Posted : January 10, 2014
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 or disease||Intervention/treatment||Phase|
|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||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Official Title:||Intraductal Therapy of DCIS: A Presurgery Study|
|Study Start Date :||February 2008|
|Estimated Primary Completion Date :||February 2011|
- Ability to identify and cannulate the duct
- Integration of the Humboldt Community Breast Health Project into the planning and execution of this study
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
|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 email@example.com|
|Principal Investigator:||Susan Love, MD, MBA||Dr. Susan Love Research Foundation|