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Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

Inclusion Criteria:

- At least 18 years of age

- Metastatic breast cancer (Stage IV) with measurable disease by RECIST criteria

- No more than three prior chemotherapy regimens either in the adjuvant or metastatic

- Histologically documented (either primary or metastatic site) breast cancer that is
ER-negative, PR-negative, and HER-2 nonoverexpressing by immunohistochemistry (0,1)
or non-gene amplified by FISH performed upon the primary tumor or metastatic lesion.
HER-2 2+ by immunohistochemistry is usually negative by FISH, and this confirmatory
test should be performed when possible, however may participate if fulfill other

- Completion of prior chemotherapy at least 3 weeks prior to study entry.

- Patients may have received therapy (ies) in the adjuvant or metastatic setting,
however must have discontinued prior to entry. Patients may receive concurrent
bisphosphonates, however if taking bisphosphonates, bone lesions may not be used for
progression or response.

- Radiation therapy must be completed at least 2 weeks prior to study entry, and
radiated lesions may not serve as measurable disease.

- Patients may have CNS metastases if stable (no evidence of progression) > 3 months
after local therapy.

- ECOG performance status 0-2 and life expectancy of at least 6 months.

- Adequate organ function defined as: ANC > 1500/mm3, plts > 100,000/mm3, creatinine
clearance >50mL/min, ALT and AST 2.5 x upper limit of normal (ULN) (or 5 x ULN in
case of liver metastases); total bilirubin 1.5 mg/dL.

- Tissue block available for EGFR studies is recommended, although will not exclude
patients from participating.

- Pregnant or lactating women will be excluded. Women of child bearing potential must
have documented negative pregnancy test within two weeks of study entry and agree to
acceptable birth control during the duration of the study therapy.

- Signed written informed consent.

Exclusion Criteria:

- Lesions identifiable only by PET.

- More than three prior chemotherapy regimens (including adjuvant). Sequential regimens
such as AC-paclitaxel are considered one regimen.

- Prior therapy which specifically and directly targets the EGFR pathway with
therapeutic intent.

- Prior platinum agent for metastatic disease. If platinum agent was used adjuvantly,
the patient must have had at least 12 months disease-free interval prior to relapse.

- Prior severe infusion reaction to a monoclonal antibody.

- Major medical conditions that might affect study participation (uncontrolled
pulmonary, renal, or hepatic dysfunction, uncontrolled infection).

- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension,
unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled
congestive heart failure, and cardiomyopathy that is either symptomatic or
asymptomatic but with decreased ejection fraction <45%

- Other significant comorbid condition which the investigator feels might compromise
effective and safe participation in the study.

- Inability to comply with the requirements of the study.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms



Washington University St. Louis, Missouri  63110