Trastuzumab and Irinotecan in Treating Patients With HER2/Neu Positive Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00303992
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : January 17, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with irinotecan may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving trastuzumab together with irinotecan works in treating patients with HER2/neu positive metastatic breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: trastuzumab Drug: irinotecan hydrochloride Phase 2

Detailed Description:



  • Determine the overall objective response-rate (partial and complete) and stable disease rate in patients with HER2/neu positive metastatic breast cancer treated with the combination of irinotecan hydrochloride and trastuzumab (Herceptin®) after prior first- or second-line therapy with trastuzumab combined with other chemotherapeutic agents.


  • Determine the toxicities of this combination regimen.
  • Determine the duration of response and time to disease progression in patients treated with this combination.
  • Document development of brain metastases or progression of known metastases in patients treated with this regimen.

OUTLINE: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, 15, and 22 and irinotecan hydrochloride IV over 30-60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weekly Trastuzumab (Herceptin) and Irinotecan in Patients With HER-2 Positive Advanced Breast Cancer: A Phase II Trial
Study Start Date : May 2004
Actual Primary Completion Date : November 16, 2006
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Trastuzumab and Irinotecan Biological: trastuzumab
Drug: irinotecan hydrochloride

Primary Outcome Measures :
  1. Overall objective response rate (partial and complete responses) [ Time Frame: up to 20 months post treatment ]
  2. Stable disease rate [ Time Frame: up to 20 months post treatment ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: up to 20 months post treatment ]
  2. Duration of response [ Time Frame: up to 20 months post treatment ]
  3. Time to disease progression [ Time Frame: up to 20 months post treatment ]
  4. Development of brain metastases or progression of known metastases on this treatment [ Time Frame: up to 20 months post treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed metastatic breast carcinoma
  • Received 1-3 prior chemotherapy regimens for metastatic disease

    • Documented progressive disease
    • Repeated courses of the same chemotherapy agent alone or in combination are considered a single regimen
    • Prior trastuzumab (Herceptin®) alone or with chemotherapy allowed

      • Other biologic agents are not considered a chemotherapy regimen
  • Measurable disease

    • Patients with bone-only disease who are evaluable by tumor markers (e.g., CA15-3, CEA, or CA27.29) are eligible

      • Patients must have prior evidence of correlation of disease activity with changes in tumor marker level
  • Confirmation of HER2/neu status by a positive test for gene amplification by fluorescence in situ hybridization or 3+ by immunohistochemistry
  • Brain metastases allowed if the following criteria are met:

    • Brain metastases were previously treated and are currently stable as documented by head CT scan with contrast or MRI within 4 weeks of study entry

      • Patients with existing brain metastases should have stability documented by prior imaging ≥ 8 weeks before the baseline scan
  • Hormone-receptor status not specified


  • Menopausal status not specified
  • ECOG performance status ≤ 2
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Life expectancy ≥ 12 weeks
  • No history of congestive heart failure
  • Documented ejection fraction ≥ 45% by MUGA scan or echocardiogram within 1 month of study entry
  • Total bilirubin < 3 times upper limit of normal (ULN)
  • AST < 3 times ULN (5 times ULN if due to liver involvement)
  • Creatinine < 1.5 times ULN
  • No history of serious adverse events related to trastuzumab
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No severe, concurrent illness that would prevent compliance with study protocol
  • No chronic severe diarrheal illness
  • No history of Gilbert's disease or known deficiency in glucuronidation
  • No recent or current history of alcoholism or acute viral hepatitis


  • See Disease Characteristics
  • No chemotherapy or hormonal therapy within the past 2 weeks
  • Prior or concurrent bisphosphonates allowed
  • No prior irinotecan (other camptothecins allowed)
  • No concurrent radiotherapy
  • No ongoing treatment with any other investigational agent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00303992

United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115-1710
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Principal Investigator: Hope S. Rugo, MD University of California, San Francisco
Principal Investigator: Judy M. Cheng, MD, PhD University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT00303992     History of Changes
Obsolete Identifiers: NCT00145821
Other Study ID Numbers: 037517
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Keywords provided by University of California, San Francisco:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action