Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery
Recruitment status was Recruiting
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Purpose
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 |
|---|---|
|
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: | 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 ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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
- 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
Contacts and Locations| 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 info@dslrf.org | |
| Principal Investigator: | Susan Love, MD, MBA | Doctor Susan Love Research Foundation |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00671476 History of Changes |
| Other Study ID Numbers: | CDR0000594671, DSLRF-SJHCA-00003154, SJHCA-00003154 |
| Study First Received: | May 2, 2008 |
| Last Updated: | June 9, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
ductal breast carcinoma in situ |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary Doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013