Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ixabepilone and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with ixabepilone and carboplatin may kill more tumor cells.

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

Further Study Information

OBJECTIVES:

Primary

• Determine the response rate in patients with HER2/neu-positive metastatic breast cancer treated with trastuzumab (Herceptin®), ixabepilone, and carboplatin.

Secondary

• Determine the time to disease progression and time to treatment failure in patients treated with this regimen.

• Determine the toxicity of this regimen in these patients.

• Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

• Induction therapy: Patients receive trastuzumab (Herceptin®) IV over 30 minutes* on days 1, 8, 15, and 22 and ixabepilone IV over 1 hour and carboplatin IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity.

NOTE: *Trastuzumab is given over 90 minutes on day 1 of course 1 (induction therapy) only.

• Maintenance therapy: Patients receive trastuzumab IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years from study entry.

PROJECTED ACCRUAL: A total of 10-60 patients will be accrued for this study within 1-6 months.

Eligibility Criteria

Inclusion criteria:

• Histologically confirmed adenocarcinoma of the breast

• Metastatic disease

• HER2/neu-positive (3+) disease by immunohistochemistry or fluorescent in situ hybridization

• At least 1 objectively measurable disease parameter

• No brain metastases as the only site of measurable disease

• Previously irradiated tumors are not considered measurable disease, except for recurrent disease located in an area of prior adjuvant irradiation (e.g., axilla or chest wall)

• Age >= 18

• ECOG performance status of 0-1

• Granulocyte count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• AST and ALT ≤ 1.5 times upper limit of normal (ULN) (2.0 times ULN for patients with liver involvement by tumor)

• Creatinine ≤ 1.5 mg/dL

• LVEF within lower limit of normal by MUGA or echocardiogram

• Negative pregnancy test

• Fertile patients must use effective nonhormonal contraception

• At least 1 week since prior hormonal therapy

• At least 2 weeks since prior radiotherapy

Exclusion criteria:

• Untreated brain metastases

• Previously treated brain metastases that have responded to prior radiotherapy and/or surgery are allowed

• New York Heart Association class III or IV heart disease

• Pregnant or nursing

• Prior severe (grade 3 or 4) hypersensitivity reaction to drugs formulated in polyoxyethylated castor oil (Cremophor EL)

• Peripheral neuropathy

• Other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• Prior trastuzumab (Herceptin®) for metastatic disease

• Concurrent pegfilgrastim

• Prior ixabepilone for metastatic disease

• Prior carboplatin or other chemotherapy for metastatic disease

• Prior cumulative doxorubicin dose > 360 mg/m^2

• Prior cumulative epirubicin dose > 640 mg/m^2

• Concurrent hormonal therapy

• Concurrent radiotherapy, including radiotherapy for brain metastases

Trial Contact Information

Trial Lead Organizations/Sponsors

Eastern Cooperative Oncology Group

Stacy L. Moulder, MD, MSCI

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00077376
Information obtained from ClinicalTrials.gov on January 10, 2012

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