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A Phase I Study Assessing the Feasibility and Safety of Intraductal Administration of Pegylated Liposomal Doxorubicin (Doxil) in Women With Breast Cancer

Phase 1
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Phase I Study Assessing the Feasibility and Safety of Intraductal Administration of Pegylated Liposomal Doxorubicin (Doxil) in Women With Breast Cancer



- Evaluate the feasibility, safety, and maximum tolerated dose of intraductal pegylated
doxorubicin HCl liposome in women with invasive breast cancer awaiting mastectomy.


- Determine the pharmacokinetics of intraductal pegylated doxorubicin HCl liposome,
including serial plasma concentrations of doxorubicin and doxorubicinol and tissue
concentrations in different portions of the breast at the time of surgery.

OUTLINE: This is a dose-escalation study.

Patients receive an intraductal injection of pegylated doxorubicin HCl liposome* on day 1.
Patients undergo mastectomy 2-4 weeks later.

Cohorts of 3-6 patients receive escalating doses of pegylated doxorubicin HCl liposome*
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At
least 6 patients are treated at the MTD.

NOTE: *The first cohort of 3 patients receive intraductal dextrose only followed by surgery
as a feasibility study.

PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.

Inclusion Criteria


- 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

- Nonpalpable tumor allowed (e.g., initial T2-3 tumor that responded to preoperative

- 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


- 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


- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility and safety after definitive surgery

Outcome Time Frame:

After definitive surgery

Safety Issue:


Principal Investigator

Vered Stearns, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

J0503 CDR0000459502



Start Date:

November 2005

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • breast cancer in situ
  • ductal breast carcinoma in situ
  • Breast Neoplasms



Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Indiana University Melvin and Bren Simon Cancer Center Indianapolis, Indiana  46202-5289