Trastuzumab and Gefitinib in Treating Patients With Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

In brief

This phase II trial is studying how well giving trastuzumab together with gefitinib works in treating patients with HER2-positive breast cancer. The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as gefitinib may also interfere with the growth of tumor cells and may enhance the effects of trastuzumab. Combining trastuzumab with gefitinib may be an effective treatment for metastatic breast cancers with high amounts of HER2

Key facts

Study ID: NCT00024154
Run by: National Cancer Institute (NCI)
People needed: 132
Starts: 2002-02-01
Last updated by the study team: 2013-01-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically confirmed metastatic adenocarcinoma of the breast
Patients may have had or not had standard first-line chemotherapy for the treatment of metastatic disease
Overexpression of HER2-neu (HER2 3+ by immunohistochemistry or gene amplification as measured by fluorescent in situ hybridization)
Measurable disease
Patients with no prior adjuvant chemotherapy may have failed or not failed first-line chemotherapy for metastatic disease
No more than 2 prior systemic chemotherapy regimens for metastatic disease
Relapse while receiving or within 6 months of completion of adjuvant chemotherapy is considered failure of 1 regimen for metastatic disease
No untreated brain metastases or brain metastases undergoing radiotherapy
Previously treated brain metastasis that has responded to radiotherapy and/or surgery allowed if not sole site of measurable disease
Hormone receptor status:
Not specified
Male or female
Performance status - ECOG 0-2
Granulocyte count at least 1,500/mm\^3
Platelet count at least 100,000/mm\^3
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST and ALT no greater than 3 times ULN (5 times ULN if liver metastases is present)
INR no greater than 1.5 times ULN
PT and PTT no greater than 1.5 times ULN
Creatinine no greater than 1.5 mg/dL
No more than trace blood or protein in urine
LVEF ≥ 50% by MUGA scan
No prior New York Heart Association class I-IV heart disease
No PR prolongation or atrioventricular block on ECG
Not pregnant or nursing

Where it is running

Eastern Cooperative Oncology Group — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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