Know Cancer

forgot password

Phase II Study of Weekly 1-Hour Paclitaxel (Taxol) Plus Recombinant Humanized Anti-p185HER2 Monoclonal Antibody (Herceptin) in the Treatment of Patients With Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Study of Weekly 1-Hour Paclitaxel (Taxol) Plus Recombinant Humanized Anti-p185HER2 Monoclonal Antibody (Herceptin) in the Treatment of Patients With Metastatic Breast Cancer

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.

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.

Inclusion 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

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Andrew D. Seidman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 1998

Completion Date:

February 2003

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



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