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

Intraductal Therapy of DCIS: A Presurgery Study

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Other: laboratory biomarker analysis; Procedure: therapeutic conventional surgery; Other: immunoenzyme technique; Genetic: DNA methylation analysis; Procedure: neoadjuvant therapy; Other: immunohistochemistry staining method; Procedure: breast duct lavage; Genetic: loss of heterozygosity analysis; Genetic: polymerase chain reaction; Drug: pegylated liposomal doxorubicin hydrochloride; Genetic: fluorescence in situ hybridization; Genetic: TdT-mediated dUTP nick end labeling assay

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Eureka, California, United States, 95501
      • Recruiting
      • St. Joseph Hospital
      • Contact: M. Ellen Mahoney, MD; Phone Number: 707-445-8121
    • Santa Monica, California, United States, 90403
      • Recruiting
      • Doctor Susan Love Research Foundation
      • Contact: Susan Love, MD, MBA; Phone Number: 866-569-0388; Email: info@dslrf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Efficacy
Ability to identify and cannulate the duct
Integration of the Humboldt Community Breast Health Project into the planning and execution of this study

Collaborators and Investigators

• Sponsor: Dr. Susan Love Research Foundation
• Investigators: Principal Investigator: Susan Love, MD, MBA, Dr. Susan Love Research Foundation

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Anticipated): February 1, 2011

Study Registration Dates

• First Submitted: May 2, 2008
• First Submitted That Met QC Criteria: May 2, 2008
• First Posted (Estimate): May 5, 2008

Study Record Updates

• Last Update Posted (Estimate): January 10, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: ductal breast carcinoma in situ
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Carcinoma in Situ; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Doxorubicin; Liposomal doxorubicin
• Other Study ID Numbers: CDR0000594671; DSLRF-SJHCA-00003154; SJHCA-00003154