Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Trastuzumab, Ixabepilone, and Carboplatin in Treating Patients With HER2/neu-Positive Metastatic Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI ECOG-E2103 NCCTG-E2103, E2103, NCT00077376

Objectives

Primary

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

Secondary

1. Determine the time to disease progression and time to treatment failure in patients treated with this regimen.
2. Determine the toxicity of this regimen in these patients.
3. Determine the overall survival of patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• 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)



• No untreated brain metastases
  • Previously treated brain metastases that have responded to prior radiotherapy and/or surgery are allowed



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy

• No prior trastuzumab (Herceptin®) for metastatic disease
• No concurrent pegfilgrastim

Chemotherapy

• No prior ixabepilone for metastatic disease
• No prior carboplatin for metastatic disease
• No other prior chemotherapy for metastatic disease
• No prior cumulative doxorubicin dose > 360 mg/m²
• No prior cumulative epirubicin dose > 640 mg/m²

Endocrine therapy

• Prior hormonal therapy for metastatic disease allowed
• At least 1 week since prior hormonal therapy
• No concurrent hormonal therapy

Radiotherapy

• See Disease Characteristics
• At least 2 weeks since prior radiotherapy
• No concurrent radiotherapy, including radiotherapy for brain metastases

Surgery

• See Disease Characteristics

Patient Characteristics:

Age

• 18 and over

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

Hepatic

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

Renal

• Creatinine ≤ 1.5 mg/dL

Cardiovascular

• LVEF within lower limit of normal by MUGA or echocardiogram
• No New York Heart Association class III or IV heart disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective nonhormonal contraception
• No prior severe (grade 3 or 4) hypersensitivity reaction to drugs formulated in polyoxyethylated castor oil (Cremophor EL)
• No peripheral neuropathy
• No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

Expected Enrollment

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

Outcomes

Objective response rate (partial and complete response)

Time to disease progression
Time to treatment failure
Overall survival
Toxicity

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.

Moulder SL, Wang M, Gradishar W, et al.: A phase II trial of trastuzumab, weekly ixabepilone and carboplatin (TIC) in patients with HER2/neu-positive (HER2+) metastatic breast cancer (MBC): a trial coordinated by the Eastern Cooperative Oncology Group (E2103). [Abstract] American Society of Clinical Oncology 2007 Breast Cancer Symposium, 7-8 September 2007, San Francisco, California A-152, 2007.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Stacy Moulder, MD, Protocol chair		Ph: 813-979-3806; 888-663-3488
Joseph Sparano, MD, Protocol co-chair		Ph: 718-904-2555 Email: jsparano@montefiore.org

North Central Cancer Treatment Group

Edith Perez, MD, Protocol chair		Ph: 507-284-1159 Email: perez.edith@mayo.edu

Registry Information
Official Title		A Phase II Trial Of Trastuzumab Plus Weekly Ixabepilone (BMS-247550) And Carboplatin In Patients With HER/Neu-Positive Metastatic Breast Cancer
Trial Start Date		2004-03-19
Registered in ClinicalTrials.gov		NCT00077376
Date Submitted to PDQ		2003-12-22
Information Last Verified		2006-03-28
NCI Grant/Contract Number		CA21115

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