Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer

A Safety Study Of Doxil And Herceptin In Patients With Advanced Her-2 Overexpressing Breast Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00006825

Enrollment

Unknown

Registered

2003-01-27

Start date

2000-07-31

Completion date

Unknown

Last updated

2011-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer

Brief summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have advanced breast cancer.

Detailed description

OBJECTIVES: * Determine the toxicity, including cardiac toxicity, of doxorubicin HCl liposome and trastuzumab (Herceptin) in women with advanced HER-2/neu-overexpressing breast cancer. * Determine the efficacy of this regimen in these patients. OUTLINE: Patients receive doxorubicin HCl liposome IV over 1 hour on day 1, followed by trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Interventions

BIOLOGICALtrastuzumab

DRUGpegylated liposomal doxorubicin hydrochloride

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically proven breast cancer * Metastatic disease OR * Locoregional relapse following optimal adjuvant therapy and regional treatment * HER-2/neu overexpression (3+ by immunohistochemistry OR gene amplification by FISH) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 10 g/dL Hepatic: * SGOT and SGPT no greater than 3 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN unless documented to be arising from bone * Bilirubin no greater than 1.5 times ULN Renal: * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Cardiovascular: * LVEF normal by radioisotope method * No history of congestive cardiac failure, myocardial infarction, cardiac arrhythmia, or ischemic heart disease requiring medication Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No known sensitivity to benzyl alcohol * No other prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * See Disease Characteristics Biologic therapy: * Not specified Chemotherapy: * No prior doxorubicin greater than 240 mg/m2 Endocrine therapy: * Not specified Radiotherapy: * Prior radiotherapy to left breast or chest wall allowed Surgery: * Not specified

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026