Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004925

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have locally advanced, inflammatory, or metastatic breast cancer.

Condition	Intervention	Phase
Breast Cancer	Drug: pegylated liposomal doxorubicin hydrochloride Drug: trastuzumab	Phase I Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase I/II Study of TLC D-99 Plus Herceptin as First or Second Line Therapy for Patients With Locally Advanced Inflammatory or Metastatic Breast Cancer

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

Study Start Date:

August 1999

Detailed Description:

OBJECTIVES:

Determine the safety, especially the cardiac safety, of doxorubicin HCl liposome and trastuzumab (Herceptin) as first- or second-line therapy in women with metastatic, inflammatory, or locally advanced breast cancer.

OUTLINE: Patients are stratified according to prior anthracycline therapy (yes vs no).

Patients receive doxorubicin HCl liposome IV over 1 hour followed 30 minutes later by trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression.

Patients are followed for at least 3 months.

PROJECTED ACCRUAL: A total of 40 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 or cytologically confirmed locally advanced, inflammatory, or metastatic adenocarcinoma of the breast that has been treated with no more than 1 prior systemic cytotoxic regimen
Overexpression of HER2 protein (2+ or 3+)
Evaluable disease
History of brain metastases allowed if off steroids and asymptomatic, with a 3 month or greater interval since last dose of brain irradiation, and no evidence of progression
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age:

18 and over

Sex:

Female

Menopausal status:

Not specified

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10 g/dL

Hepatic:

Bilirubin no greater than 1.5 times upper limit of normal (ULN)

Renal:

AST or ALT no greater than 4 times ULN

Cardiovascular:

Adequate cardiac function
LVEF at least 50% predicted or lower limit of normal

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other concurrent medical or psychological condition that would preclude study compliance
No history of hypersensitivity to anthracyclines, eggs, or egg products

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Prior trastuzumab (Herceptin) allowed

Chemotherapy:

See Disease Characteristics
At least 3 weeks since prior antineoplastic therapy
No more than 1 prior systemic cytotoxic regimen for locally advanced, metastatic, or inflammatory breast cancer
No prior anthracyclines greater than 240 mg/m2
No other concurrent antineoplastic agents
No concurrent treatment with other liposomal products other than doxorubicin HCl liposome

Endocrine therapy:

See Disease Characteristics
At least 3 weeks since prior hormonal agents
No concurrent hormonal therapy

Radiotherapy:

See Disease Characteristics

Surgery:

Not specified

Other:

At least 3 weeks since other prior investigational drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004925

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Maria Theodoulou, MD

Memorial Sloan-Kettering 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:	CDR0000067609, MSKCC-99054, LIPO-D9905, NCI-G00-1684
Study First Received:	March 7, 2000
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00004925
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV breast cancer
recurrent breast cancer
stage IIIB breast cancer
inflammatory breast cancer

Study placed in the following topic categories:

Inflammatory breast cancer
Skin Diseases
Trastuzumab
Breast Neoplasms

Doxorubicin
Breast Diseases
Recurrence

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