Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00671476
First received: May 2, 2008
Last updated: January 9, 2014
Last verified: June 2009
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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)
Detailed Description:

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671476

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   
Sponsors and Collaborators
Doctor Susan Love Research Foundation
Investigators
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: January 9, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
ductal breast carcinoma in situ

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Breast Diseases
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Skin Diseases
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014