Status:
COMPLETED
Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ch...
Detailed Description
OBJECTIVES: Primary * Evaluate the feasibility, safety, and maximum tolerated dose of intraductal pegylated doxorubicin HCl liposome in women with invasive breast cancer awaiting mastectomy. Second...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed infiltrating carcinoma of the breast meeting any of the following criteria:
- T1-3, any N disease
- Proven ductal carcinoma in situ
- Unresected disease
- Planned mastectomy as definitive surgical procedure
- Known or suspected metastatic disease allowed provided mastectomy is planned
- Nonpalpable tumor allowed (e.g., initial T2-3 tumor that responded to preoperative therapy)
- No inflammatory breast cancer or other T4 features
- Successful baseline ductogram
- Baseline nipple aspiration procedure must identify a duct productive of nipple aspirate fluid
- No severe nipple retraction
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Female patients
- Menopausal status not specified
- ECOG performance status 0-2
- Absolute neutrophil count ≥1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 9.0 g/dL
- Creatinine ≤ 2 times upper limit of normal (ULN)
- Bilirubin ≤ 2 times ULN
- AST and ALT ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant history of severe allergy to iodinated contrast material or debilitating anxiety that may not allow for a ductogram
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior preoperative chemotherapy, trastuzumab (Herceptin®), or hormonal therapy allowed provided it was completed 7-14 days prior to study treatment
- No prior radiation therapy, excisional biopsy, breast reduction, areolar surgery, or breast implant (present or past history of implant that was removed)
- No other prior procedure that may have altered the breast ductal system in the ipsilateral breast
- No other concurrent chemotherapy, radiotherapy, endocrine therapy, or biologic agents for breast cancer
- No other concurrent investigational drugs
- Concurrent bisphosphonates allowed
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00290732
Start Date
November 1 2005
End Date
October 1 2011
Last Update
October 31 2013
Active Locations (2)
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1
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410