Status:
UNKNOWN
Doxorubicin Hydrochloride Liposome in Treating Women With Ductal Carcinoma in Situ Undergoing Surgery
Lead Sponsor:
Dr. Susan Love Research Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 dividi...
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 de...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00671476
Start Date
February 1 2008
Last Update
January 10 2014
Active Locations (2)
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1
St. Joseph Hospital
Eureka, California, United States, 95501
2
Doctor Susan Love Research Foundation
Santa Monica, California, United States, 90403