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Phase II Study of the Trifunctional Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab for Hormone Therapy Refractory Patients With Her-2/Neu 1+ or 2+ Expressing Advanced or Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Neoplasms, Breast Cancer

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Trial Information

Phase II Study of the Trifunctional Anti-HER-2/Neu x Anti-CD3 Antibody Ertumaxomab for Hormone Therapy Refractory Patients With Her-2/Neu 1+ or 2+ Expressing Advanced or Metastatic Breast Cancer

A multi-centre, phase II study of ertumaxomab in metastatic breast cancer patients who
became progressive after hormonal therapy. Each eligible patient will receive three
ascending doses of ertumaxomab, administered intravenously. Ertumaxomab will be administered
as a 3-hour constant rate infusion with a dosing interval of 7 days. Each patient will
participate in this study for up to 7 months (includes the up to 21 days screening period,
14 days treatment period, and up to 180 days/6 months follow-up), with 3-monthly post-study
follow-up until the patient becomes progressive.

Inclusion Criteria:

- Female gender, and if of child-bearing potential must have negative pregnancy test
result within 2 days before enrolment and must agree to practice effective birth
control during the study.

- Aged 18 years and older.

- Histologically or cytologically confirmed invasive breast cancer with stage IIIb or
IV disease with documented progression.

- Measurable disease according to RECIST.

- Histologically documented advanced primary breast cancer or biopsy of metastatic site
demonstrating HER-2/neu expression (HER-2/neu 1+ or 2+, determined by
immunohistochemistry [IHC]). HER-2/neu 2+ patients must have a negative Fluorescence
In Situ Hybridization [FISH] test result.

- Hormone receptor status Estrogen Receptors (ERs) positive and/or Progesterone
Receptors (PRs) positive.

- No prior treatment with mouse or rat antibodies.

- Life expectancy of at least six months (if the life expectancy of a patient is
unspecified she will be allowed to enter the study).

- An Eastern Cooperative Oncology Group (ECOG) performance score of £ 1.

- Patients must have had disease progression after hormonal therapy including at least
one aromatase inhibitor.

- Adequate hematological, liver and kidney function:

- Thrombocytes ³ 100000 / mm³ (= 100 x 109 /l)

- Hemoglobin ³ 10 g/dl

- Neutrophil count ³ 1500/mm³ (= 1.5 x 109 /l)

- WBC ³ 3 X 109 /l

- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvate
transaminase (SGPT) ≤ 2.5 x upper limit of normal (ULN)

- Serum bilirubin ≤ 2 x ULN

- Creatinine ≤ 1.5 x ULN or clearance ³ 60 ml/min

- No life-threatening visceral disease.

- No known brain or central nervous system metastases.

- No symptomatic pleural effusions.

- No symptomatic pericardial effusions.

- No subjects whose only site of metastatic involvement is bone metastases with the
exception of those with a measurable soft tissue component of the bone lesion seen
with imaging that does not require palliative radiation intervention and/or the
patient has a lytic bone lesion ³ 1 cm measured with radiography that can be followed
for evidence of re-calcification.

- No history of relevant cardiovascular disease:

- LVEF within the institutional ranges of normal as measured by echocardiogram or
MUGA scan

- No prior uncontrolled or symptomatic congestive heart failure NYHA ³ 2

- No myocardial infarction within the past two years

- No uncontrolled or symptomatic cardiac arrhythmias

- No severe dyspnea.

- No pulmonary dysfunction or need for continuous supportive oxygen inhalation.

- No other concurrent uncontrolled co-morbid illness.

- No other concurrent malignancy, except treated basal cell or squamous cell carcinoma
of the skin, or in situ carcinoma of the cervix.

- Patients with documented autoimmune diseases (such as lupus) are excluded from
participation in the study unless a waiver is granted by the responsible medical

- Patients with a human immunodeficiency virus, hepatitis B or hepatitis C positive
status are excluded from participation in the study.

- No prior or concurrent chemotherapy regimen for advanced or metastatic disease.

- Prior neo-adjuvant or adjuvant chemotherapy is allowed provided it was stopped at
least six months before study entry.

- No concurrent hormone therapy (hormone therapy must be stopped at the screening

- At least 4 weeks since prior radiotherapy.

- No concurrent immune therapy.

- No concurrent corticosteroid therapy.

- No regularly used medication for a health condition or comorbidity that might result
in undue risk to the patient.

- No prior investigational treatment for advanced or metastatic disease.

- Able and willing to comply fully with the protocol.

Type of Study:


Study Design:

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

Outcome Measure:

To demonstrate clinical efficacy of the investigational trifunctional antibody ertumaxomab for the treatment of hormone therapy refractory advanced or metastatic breast cancer tumors (stage IIIb or IV) which are known to express Her-2/neu (1+ or 2+)

Principal Investigator

Fatima Cardoso, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Study ID:




Start Date:

July 2006

Completion Date:

February 2009

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer
  • Breast Cancer
  • investigational drug
  • drug therapy
  • Antineoplastic Protocols
  • Immunotherapy
  • Metastatic breast cancer
  • Advanced breast cancer
  • Stage III to IV breast cancer
  • Hormonal therapy refractory
  • Failure of hormonal therapy
  • Her-2/neu expressing breast cancer
  • low to moderate Her-2/neu expression
  • Breast Neoplasms
  • Neoplasms