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

Breast Cancer Clinical Trial

Official title:

Intraductal Therapy of DCIS: A Presurgery Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00671476
• Other study ID #: CDR0000594671
• Secondary ID: DSLRF-SJHCA-0000
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2008
• Last updated: January 9, 2014
• Start date: February 2008

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ

Intervention

Drug:
• pegylated liposomal doxorubicin hydrochloride

Genetic:
• DNA methylation analysis

• TdT-mediated dUTP nick end labeling assay

• fluorescence in situ hybridization

• loss of heterozygosity analysis

• polymerase chain reaction

Other:
• immunoenzyme technique

• immunohistochemistry staining method

• laboratory biomarker analysis

Procedure:
• breast duct lavage

• neoadjuvant therapy

• therapeutic conventional surgery

Locations

Country	Name	City	State
United States	St. Joseph Hospital	Eureka	California
United States	Doctor Susan Love Research Foundation	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Susan Love Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy			No
Primary	Safety			Yes
Primary	Ability to identify and cannulate the duct			No
Primary	Integration of the Humboldt Community Breast Health Project into the planning and execution of this study			No