Recruiting

Doxorubicin Hydrochloride

Sponsor:

Dr. Susan Love Research Foundation

Code:

NCT00671476

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

pegylated liposomal doxorubicin hydrochloride

DNA methylation analysis

TdT-mediated dUTP nick end labeling assay

fluorescence in situ hybridization

loss of heterozygosity analysis

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT00671476

Start date

Feb, 2008

Status verified date

Jun, 2009

Primary completion date

Feb, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

pegylated liposomal doxorubicin hydrochloride

DNA methylation analysis

TdT-mediated dUTP nick end labeling assay

fluorescence in situ hybridization

loss of heterozygosity analysis

polymerase chain reaction

immunoenzyme technique

immunohistochemistry staining method

laboratory biomarker analysis

breast duct lavage

neoadjuvant therapy

therapeutic conventional surgery

Primary outcome measure

  • Efficacy [ Time Frame: undefined ]
  • Safety [ Time Frame: undefined ]
  • Ability to identify and cannulate the duct [ Time Frame: undefined ]
  • Integration of the Humboldt Community Breast Health Project into the planning and execution of this study [ Time Frame: undefined ]

Central Contacts and Locations

Locations

St. Joseph Hospital

Recruiting

Eureka, California, United States, 95501

Contacts

M. Ellen Mahoney, MD

707-445-8121

Doctor Susan Love Research Foundation

Recruiting

Santa Monica, California, United States, 90403

Contacts

Susan Love, MD, MBA

866-569-0388info@dslrf.org

More Information

Sponsor

Dr. Susan Love Research Foundation

Last update posted

Jan 10, 2014

Last verified

Jun, 2009

Keywords

  • ductal breast carcinoma in situ

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dr. Susan Love Research Foundation on 2014-01-10.