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Sponsored by: |
Doctor Susan Love Research Foundation |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00671476 |
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 | Intervention |
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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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control |
Official Title: | Intraductal Therapy of DCIS: A Presurgery Study |
Estimated Enrollment: | 30 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of ductal breast carcinoma in situ by core needle biopsy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
Doctor Susan Love Research Foundation | Recruiting |
Santa Monica, California, United States, 90403 | |
Contact: Susan Love, MD, MBA 866-569-0388 info@dslrf.org | |
St. Joseph Hospital | Recruiting |
Eureka, California, United States, 95501 | |
Contact: M. Ellen Mahoney, MD 707-445-8121 |
Principal Investigator: | Susan Love, MD, MBA | Doctor Susan Love Research Foundation |
Study ID Numbers: | CDR0000594671, DSLRF-SJHCA-00003154, SJHCA-00003154 |
Study First Received: | May 2, 2008 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00671476 History of Changes |
Health Authority: | Unspecified |
ductal breast carcinoma in situ |
Carcinoma, Ductal Anti-Bacterial Agents Skin Diseases Carcinoma in Situ Breast Neoplasms Carcinoma, Ductal, Breast |
Carcinoma, Intraductal, Noninfiltrating Adenocarcinoma Doxorubicin Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms by Histologic Type Skin Diseases Antineoplastic Agents Breast Neoplasms Antibiotics, Antineoplastic Pharmacologic Actions Doxorubicin Carcinoma Neoplasms |
Neoplasms by Site Therapeutic Uses Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |