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Weekly Trastuzumab (Herceptin) and Irinotecan in Patients With HER-2 Positive Advanced Breast Cancer: A Phase II Trial

Phase 2
Open (Enrolling)
Breast Cancer

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Trial Information

Weekly Trastuzumab (Herceptin) and Irinotecan in Patients With HER-2 Positive Advanced Breast Cancer: A Phase II Trial



- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall objective response rate (partial and complete responses)

Outcome Time Frame:

up to 20 months post treatment

Safety Issue:


Principal Investigator

Hope S. Rugo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Food and Drug Administration

Study ID:




Start Date:

May 2004

Completion Date:

December 2013

Related Keywords:

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



UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California  94115