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A Phase II Trial Of Trastuzumab Plus Weekly Ixabepilone (BMS-247550) And Carboplatin In Patients With HER/Neu-Positive Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase II Trial Of Trastuzumab Plus Weekly Ixabepilone (BMS-247550) And Carboplatin In Patients With HER/Neu-Positive Metastatic Breast Cancer


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


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

II. Determine the toxicity of this regimen in these patients. III. 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

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.

Inclusion Criteria

Inclusion criteria:

- Histologically confirmed adenocarcinoma of the breast

- Metastatic disease

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response for HER2+ Patients (Best Objective Response a Patient Has Ever Experienced on Study)

Outcome Description:

To assess objective response, it is necessary to estimate the overall tumor burden at baseline to which subsequent measurements will be compared. The same method of assessment and the same technique should be used to characterize each lesion at baseline and during follow-up. The best overall response based on RECIST is the best response recorded from registration until disease progression/recurrence, taking as reference for progressive disease the smallest measurements recorded since registration. The best response was determined based on the tumor responses in target and nontarget lesions, with or without new lesions. To be assigned a status of complete or partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 8 weeks.

Outcome Time Frame:

Assessed every 3 cycles during induction therapy and every 6 cycles during maintenance therapy until disease progression or up to 5 years

Safety Issue:


Principal Investigator

Stacy L. Moulder, MD, MSCI

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 2004

Completion Date:

March 2011

Related Keywords:

  • Breast Cancer
  • Trastuzumab
  • Ixabepilone
  • Carboplatin
  • HER2/Neu-Positive
  • Metastatic Breast Cancer
  • Breast Neoplasms



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