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A Phase II Open-Label Trial to Evaluate the Efficacy and Toxicity of Tarceva (Erlotinib) in Women With Metastatic, Hormone Receptor Negative and Her2-Negative Breast Cancer

Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

A Phase II Open-Label Trial to Evaluate the Efficacy and Toxicity of Tarceva (Erlotinib) in Women With Metastatic, Hormone Receptor Negative and Her2-Negative Breast Cancer

This is a Phase II, open-label, single institution trial of treatment with single agent
erlotinib. The purpose of the research is to determine the effects erlotinib has on the
breast cancer tumors in women with metastatic hormone receptor negative and HER2-negative
breast cancer. The Federal Drug Administration (FDA) has approved erlotinib, also known as
Tarceva, for the treatment of locally advanced and metastatic non-small cell lung cancer.

To qualify for the trial, subjects must have histologically confirmed, incurable, locally
advanced or metastatic breast cancer that is ER-negative, PR-negative, Her2/neu-negative and
EGFR-positive. Subjects must have measurable disease. They must have received less than or
equal to 1 chemotherapeutic agent in the metastatic setting. The target accrual is 43
subjects. Initially, 18 subjects will be accrued. If at least 3 subjects are
progression-free at 4 months, accrual will continue to a maximum of 43 subjects. Subject
eligibility will be evaluated during a screening period of 4 weeks. During the treatment
period, subjects will receive single agent erlotinib, 150mg/day. Subjects will receive the
first dose of erlotinib on Day 0, within 7 days of registration. Efficacy will be assessed
by radiographic tumor assessment or photographic documentation. Safety will be assessed by
the recording of adverse events and laboratory test results. Subjects with documented
progressive disease will be discontinued from treatment and will be followed for survival
information every 2 months until death, lost to follow-up or study termination.

Inclusion Criteria:

1. Verbal and written informed consent to participate in the study.

2. Women greater than or equal to 18 years of age.

3. Histologically documented metastatic or locally advanced, incurable breast cancer
with a tumor block available

4. Less than or equal to 1 prior chemotherapy for metastatic or locally unresectable

5. Prior treatment with anthracycline and taxane chemotherapy, either in the adjuvant or
metastatic setting

6. Measurable disease on CT or PET scan or physical exam Disease at a previously
irradiated site is considered measurable if there is clear evidence of disease
progression following radiation therapy.

7. ER-negative, PR-negative and HER2-neu-negative. Estrogen and progesterone status
will be defined by immunohistochemistry. Her2/neu status will be considered negative
if the ratio of the number of copies of the Her2/neu gene to the centromeric probe
for chromosome 17 is approximately 1. This will be done by FISH (fluorescent in-situ
hybridization) testing.

8. EGFR-positive defined as strong membrane staining in greater than 10% of tumor cells
by immuno-histochemistry (Dako).

9. Pre- or post-menopausal.

10. ECOG performance status of 0 - 2.

11. Life expectancy of greater than or equal to 3 months.

12. Use of barrier contraceptive methods in women of childbearing potential.

13. Ability to comply with study and follow-up procedures.

Exclusion Criteria:

1. Pleural effusions or blastic bone lesions as the only manifestations of the current
metastatic breast cancer.

2. Other primary malignancies within 5 years except for adequately treated carcinoma in
situ of the cervix or basal or squamous cell skin cancer.

3. Symptomatic or untreated brain metastases. Subjects are eligible if they are
neurologically stable after treatment for brain metastases and have been off steroids
for greater than or equal to 4 weeks.

4. Radiotherapy, immunotherapy, hormonal therapy or chemotherapy within 21 days prior to

5. Prior treatment with an agent that targets the EGFR or the EGFR-specific tyrosine
kinase activity.

6. Unstable systemic disease, including active infection, uncontrolled hypertension,
unstable angina, congestive heart failure, or myocardial infarction within 6 months
prior to Day 0, or serious cardiac arrhythmias requiring medication.

7. Major surgery, biopsy of a parenchymal organ, or significant traumatic injury
occurring within 21 days prior to Day 0.

8. History of other diseases, metabolic dysfunction, physical examinations findings, or
clinical laboratory finding giving reasonable suspicion of a disease or condition
that contraindicates the use of an investigational drug or that might affect the
interpretation of the results of the study or render the patient at high risk from
treatment complications.

9. Gastrointestinal tract disease resulting in an inability to take oral medication or a
requirement for IV alimentation, prior surgical procedures affecting absorption, or
active peptic ulcer disease.

10. Pregnancy or lactation. A negative serum or urine pregnancy test is required for
women of child-bearing potential during screening and within 7 - 10 days of Day 1 of
Cycle 1 of erlotinib (Tarcevo®)administration. Men and premenopausal women of child
bearing potential will follow an approved, medically accepted birth control regimen
while taking erlotinib and for 30 days following the last dose of study drug.

11. Active infection requiring parenteral antibiotics.

12. Any of the following abnormal baseline hematologic values:

- Granulocyte count less than or equal to 1500/μL

- Platelet count less than or equal to 100,000/μL

- Hemoglobin less than or equal to 9g/dl (transfusion permitted)

13. Any of the following abnormal baseline liver function tests:

- Serum bilirubin greater than or equal to 1.5x upper limit of normal (ULN)

- Serum ALT and AST greater than or equal to 2.5x ULN (greater than 5x ULN if due
to liver metastases)

- Alkaline phosphatase greater than or equal to 2.5x ULN (greater than 4x ULN if
due to liver or bone metastases)

14. Other baseline laboratory values:

- Serum creatinine greater than or equal to 1.5x ULN or creatinine clearance less
than or equal to 60mL/min

- Uncontrolled hypercalcemia (greater than 11.5mg/dL)

Type of Study:


Study Design:

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

Outcome Measure:

The primary objective of the study is to determine progression free survival. This is defined as the time from the day of initial treatment (Day 0) until documented disease progression or death.

Outcome Time Frame:

Cannot be determined

Safety Issue:


Principal Investigator

Ruta D Rao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rush University Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2007

Completion Date:

April 2011

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic breast cancer
  • ER and PR hormone receptor negative
  • HER2/neu negative
  • EGFR positive
  • Breast Neoplasms



Rush University Medical Center Division of Hematology/OncologyChicago, Illinois  60612