Phase II Study of Paclitaxel in Combination with Monoclonal Antibody HER2 (Herceptin) in Women with Recurrent or Metaststic Breast Cancer (Summary Last Modified 07/2000). Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. cannot verify the accuracy of the information.

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Alternate Title

Paclitaxel Plus Monoclonal Antibody Therapy in Treating Women With Recurrent or Metastatic Breast Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. cannot verify the accuracy of the information.

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentCompleted18 and overNCIMSKCC-98028
NCI-G98-1473, NCT00003539


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.

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

 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

 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

 At least 2-3 weeks since prior surgery and recovered
 No concurrent surgery to the only measurable lesion

 No concurrent nonprotocol treatment

Patient Characteristics:

 18 and over


Menopausal status:
 Not specified

Performance status:
 Karnofsky 70-100%

Life expectancy:
 Not specified

 Granulocyte count at least 1500/mm3
 Hemoglobin at least 8.0 g/dL
 Platelet count at least 100,000/mm3

 Bilirubin less than 1.5 mg/dL

 Creatinine less than 2.0 mg/dL
 Calcium no greater than 11.0 mg/dL

 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%

 No symptomatic lymphangitic pulmonary metastases

 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

Expected Enrollment


This study will accrue 50 patients in approximately 6 months.


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.

Published Results

Seidman AD, Fornier MN, Esteva FJ, et al.: Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 immunophenotype and gene amplification. J Clin Oncol 19 (10): 2587-95, 2001.[PUBMED Abstract]

Seidman AD, Fornier M, Esteva F, et al.: Final report: weekly herceptin and taxol for metastatic breast cancer: analysis of efficacy by HER2 immunophenotype [immunohistochemistry (IHC)] and gene amplification [fluorescent in-situ hybridization (FISH)]. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A319, 2000.

Fornier M, Seidman AD, Esteva FJ, et al.: Weekly herceptin plus one hour taxol: phase II study in HER2 overexpressing (H2+) and non-overexpressing (H2-) metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A482, 1999.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Andrew Seidman, MD, Protocol chair
Ph: 212-639-5875; 800-525-2225

Registry Information

Official TitlePhase 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
Trial Start Date1998-04-28
Trial Completion Date2003-02-25
Registered in ClinicalTrials.govNCT00003539
Date Submitted to PDQ1998-08-13
Information Last Verified2009-12-01

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.