Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or M… (NCT00004925) | Clinical Trial Compass
CompletedPhase 1/2
Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer
United StatesStarted 1999-08
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…