RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies 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 cancer cells.

PURPOSE: Phase II trial to study the effectiveness of paclitaxel plus monoclonal antibody therapy in treating women with recurrent or metastatic breast cancer.

Condition	Treatment or Intervention	Phase
stage IV breast cancer recurrent breast cancer	Drug: paclitaxel  Drug: trastuzumab	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the therapeutic efficacy of paclitaxel in combination with monoclonal antibody HER2 (Herceptin) in women with recurrent or metastatic breast cancer.

II. Evaluate the safety of this combination regimen in these patients.

PROTOCOL OUTLINE: Patients are stratified by tumor expression of HER2 (overexpression vs normal).

Patients receive a loading dose of monoclonal antibody HER2 (Herceptin) intravenously over 90 minutes on day 0. Paclitaxel is administered intravenously over 1 hour on day 1.

Starting on day 7, patients receive paclitaxel by infusion over 1 hour every 7 days. Monoclonal antibody HER2 is administered intravenously over 30 minutes immediately following paclitaxel every 7 days. Treatment continues in the absence of disease progression and unacceptable toxicity.

Patients are followed until death.

PROJECTED ACCRUAL: This study will accrue 50 patients in approximately 6 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed recurrent or metastatic breast cancer
• Bidimensionally measurable disease; No bone scan abnormalities alone; Lytic lesions allowed in conjunction with bone scan abnormalities; No pure blastic bone metastases; No pleural or peritoneal effusions; No previously irradiated lesions
• Resected disease not allowed
• No brain metastases or leptomeningeal disease
• Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

• Biologic therapy: No prior monoclonal antibody therapy
• Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered; No more than 3 prior chemotherapy regimens as adjuvant/neoadjuvant therapy or for disease; At least 1 year since prior paclitaxel or docetaxel; Prior anthracycline (doxorubicin or epirubicin) or mitoxantrone-based regimen allowed as adjuvant therapy or for advanced disease; No other concurrent chemotherapy
• Endocrine therapy: At least 3 weeks since prior exogenous hormonal therapy for stage IV disease and/or as adjuvant therapy
• Radiotherapy: No radiotherapy to greater than 50% of marrow; At least 4 weeks since prior radiotherapy and recovered; No concurrent radiotherepy to the only measurable lesion
• Surgery: At least 2-3 weeks since prior surgery and recovered; No concurrent surgery to the only measurable lesion
• Other: No concurrent nonprotocol treatment

--Patient Characteristics--

• Age: 18 and over
• Sex: Female
• Menopausal status: Not specified
• Performance status: Karnofsky 70-100%
• Life expectancy: Not specified
• Hematopoietic: Granulocyte count at least 1500/mm3; Hemoglobin at least 8.0 g/dL; Platelet count at least 100,000/mm3
• Hepatic: Bilirubin less than 1.5 mg/dL
• Renal: Creatinine less than 2.0 mg/dL; Calcium no greater than 11.0 mg/dL
• Cardiovascular: No history of arrhythmias; No history of other significant cardiac diseases; No New York Heart Association class III or IV cardiac function; Left ventricular ejection fraction at least 50%
• Pulmonary: No symptomatic lymphangitic pulmonary metastases
• Other: Not pregnant; Negative pregnancy test; No history of other malignancy except: Carcinoma in situ of the cervix; Curatively treated nonmelanoma skin cancer; No severe infection; No severe malnutrition; No other serious medical illness; No history of grade 3-4 peripheral neuropathy

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

Study chairs or principal investigators

Andrew D. Seidman,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000066593; MSKCC-98028; NCI-G98-1473
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003539
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08