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Phase II Trial of OSI-774 (Tarceva), a Human Epidermal Growth Factor (HER) (erbB, Also Known as Epidermal Growth Factor Receptor, EGFR) Tyrosine Kinase Inhibitor, in Treatment-Naïve Operable Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Trial of OSI-774 (Tarceva), a Human Epidermal Growth Factor (HER) (erbB, Also Known as Epidermal Growth Factor Receptor, EGFR) Tyrosine Kinase Inhibitor, in Treatment-Naïve Operable Breast Cancer



- To determine the in situ antitumor effect of neoadjuvant erlotinib hydrochloride as
measured by a reduction in Ki67 and/or an increase in terminal deoxynucleotidyl
transferase-mediated deoxyuridine triphosphate-biotin nick end labeling
(TUNEL)-positive tumor cells in patients with treatment-naive, operable breast cancer.


- To identify a molecular profile, based on measurements of Estrogen Receptor (ER),
Epidermal Growth Factor Receptor (EGFR), and a Human Epithelial Growth Factor
Receptor-2(HER2), and protein expression profiles in patients with treatment-naïve,
operable breast cancer that is responsive to erlotinib hydrochloride.

- To correlate tumor concentrations of erlotinib hydrochloride with serum levels
immediately before surgery.

OUTLINE: This is a multi-center study.

Patients receive oral erlotinib hydrochloride once daily for 5-14 days. Patients then
undergo surgical resection within 24 hours after the last dose of erlotinib hydrochloride.

Tumor tissue samples are collected at baseline and during surgery for correlative laboratory
studies. Tissue samples are stained for ER, HER2, and EGFR levels, proliferation (Ki67), and
apoptosis (TUNEL) by immunohistochemistry. Levels of erlotinib hydrochloride in tissue
samples are measured by matrix-assisted laser desorption/ionization mass spectrometry. Blood
samples are collected on the day of surgery. Levels of erlotinib hydrochloride in blood
samples are measured by liquid chromatography/mass spectrometry.

Patients are followed within 6 weeks after surgery.

Inclusion Criteria:

- Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma

- Diagnosis may be made by fine needle aspiration cytology or core biopsy

- A repeat core biopsy is not required for patients who have a paraffin
embedded diagnostic core biopsy specimen available for immunohistochemical

Exclusion Criteria:

- Patients with locally advanced disease who are planning to undergo preoperative
neoadjuvant therapy are not eligible*

- Locally advanced disease includes any of the following:

- Primary tumor ≥ 5 cm (T3)

- Tumor of any size with direct extension to the chest wall or skin (T4a-c)

- Inflammatory breast cancer (T4d)

- Fixed axillary lymph node metastases (N2)

- Metastasis to ipsilateral internal mammary node (N3) NOTE: *Patients with
primary tumors ≥ 5 cm (T3) or tumors involving the chest wall or skin who
are not candidates for preoperative chemotherapy or who decline
preoperative chemotherapy are eligible

- Measurable residual tumor at the primary site

- Measurable disease is defined as any mass that can be reproducibly measured by
physical examination

- Planning to undergo surgical treatment with either segmental resection or total

- Patients with a prior history of contralateral breast cancer are eligible if they
have no evidence of recurrence of their initial primary breast cancer

- No locally recurrent breast cancer

- No evidence of distant metastatic disease (i.e., lung, liver, bone, or brain

- Hormone receptor status not specified


- Menopausal status not specified

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- ANC ≥ 1,000/mm^3

- Creatinine ≤ 1.5 times upper limit of normal (ULN)

- Total bilirubin ≤ 1.5 times ULN

- Serum glutamic oxaloacetic transminase (SGOT) and serum glutamic pyruvic transminase
(SGPT) ≤ 1.5 times ULN

- Must be at least 18 years old

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No serious medical illness that, in the judgement of the treating physician, places
the patient at high risk of operative mortality


- See Disease Characteristics

- No prior chemotherapy for this primary breast cancer

- At least 7 days since prior tamoxifen or raloxifene as a preventive agent

Type of Study:


Study Design:

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

Outcome Measure:

Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva

Outcome Description:

In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.

Outcome Time Frame:

5-14 days

Safety Issue:


Principal Investigator

Carlos L. Arteaga, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2002

Completion Date:

October 2007

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms



Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Meharry Medical College Nashville, Tennessee  37208-3599
University of Alabama, Birmingham Birmingham, Alabama  35233
Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina  27599-7305