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Liposomal Doxorubicin Before Mastectomy in Treating Women With Invasive Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), September 2007
Sponsors and Collaborators: Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00290732
  Purpose

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 chemotherapy in different ways, such as into the breast ducts, may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I trial is studying the side effects and best dose of liposomal doxorubicin when given before mastectomy in treating women with invasive breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: pegylated liposomal doxorubicin hydrochloride
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Phase I

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Mastectomy
Drug Information available for: Doxorubicin Doxorubicin hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study Assessing the Feasibility and Safety of Intraductal Administration of Pegylated Liposomal Doxorubicin (Doxil) in Women With Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Feasibility and safety after definitive surgery [ Designated as safety issue: Yes ]
  • Maximum tolerated dose (MTD) after definitive surgery [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics in blood and tissue after definitive surgery [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: November 2005
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
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.

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290732

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce     410-955-8804     jhcccro@jhmi.edu    
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000459502, JHOC-J0503, JHOC-05030803
Study First Received: February 9, 2006
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00290732  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Skin Diseases
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Doxorubicin
Breast Diseases
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009