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
18 Years
N/A
Female
Breast Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Maria Theodoulou, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
99-054
NCT ID:
NCT00004925
Start Date:
August 1999
Completion Date:
August 2003
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- inflammatory breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
