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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of California, San Francisco Identifier:
First received: March 15, 2006
Last updated: August 15, 2014
Last verified: August 2014

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 Intervention Phase
Breast Cancer
Biological: trastuzumab
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Overall objective response rate (partial and complete responses) [ Time Frame: up to 20 months post treatment ] [ Designated as safety issue: No ]
  • Stable disease rate [ Time Frame: up to 20 months post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: up to 20 months post treatment ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: up to 20 months post treatment ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: up to 20 months post treatment ] [ Designated as safety issue: No ]
  • Development of brain metastases or progression of known metastases on this treatment [ Time Frame: up to 20 months post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2004
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Trastuzumab and Irinotecan Biological: trastuzumab Drug: irinotecan hydrochloride

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.


Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
Principal Investigator: Hope S. Rugo, MD University of California, San Francisco
Principal Investigator: Judy M. Cheng, MD, PhD University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco Identifier: NCT00303992     History of Changes
Obsolete Identifiers: NCT00145821
Other Study ID Numbers: CDR0000465211, UCSF-037517, UCSF-H6961-24269-02A
Study First Received: March 15, 2006
Last Updated: August 15, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on October 21, 2014