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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

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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Stacy L. Moulder, MD, MSCI
Trial Interventions
Biological
  • trastuzumab
Drug
  • carboplatin
  • ixabepilone
Physician Researcher

Investigator Name:

  • Stacy L. Moulder, MD, MSCI

Other Information

Sponsor: Eastern Cooperative Oncology Group
Phase: Phase 2
Trial ID: NCT00077376
Volunteers:  Not Accepting Healthy Volunteers

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