Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery - Full Text View

Sponsors and Collaborators:	Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00633750

Purpose

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with breast cancer that can be removed by surgery.

Condition	Intervention	Phase
Breast Cancer	Drug: erlotinib hydrochloride Genetic: TdT-mediated dUTP nick end labeling assay Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Trial of OSI-774 (Tarceva), a HER (erbB) Tyrosine Kinase Inhibitor, in Treatment-Naïve Operable Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

In situ antitumor effect of erlotinib hydrochloride as measured by a reduction in Ki67 and/or an increase in TUNEL-positive tumor cells [ Designated as safety issue: No ]

Secondary Outcome Measures:

Identification of molecular profiles as measured by ER, EGFR, and HER2, and protein expression profiles [ Designated as safety issue: No ]
Correlation of tumor concentrations of erlotinib hydrochloride with serum levels immediately before surgery [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	August 2002
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

To determine the in situ antitumor effect of neoadjuvant erlotinib hydrochloride as measured by a reduction in Ki67 and/or an increase in TUNEL-positive tumor cells in patients with treatment-naive, operable breast cancer.

Secondary

To identify a molecular profile, based on measurements of ER, EGFR, and 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 multicenter 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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 staining
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 mastectomy
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 metastases)
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified
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
SGOT and SGPT ≤ 1.5 times ULN
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

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior chemotherapy for this primary breast cancer
At least 7 days since prior tamoxifen or raloxifene as a preventive agent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633750

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Carlos L. Arteaga, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000583160, VU-VICC-BRE-0222, VU-VICC-020448
Study First Received:	March 11, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00633750 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Study placed in the following topic categories:

Erlotinib
Skin Diseases
Tyrosine

Breast Neoplasms
Protein Kinase Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Erlotinib
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases

Breast Neoplasms
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009