Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery

NCT00633750 | Completed Phase 2 Results DMC

• 5 other identifiers: VICC BRE 0222VU-VICC-BRE-0222VU-VICC-020448P50CA098131R01CA080195
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  5-14 days

Secondary Outcomes (2)

• Molecular Profile of Participants Who Are Responsive to Tarceva

  at 5-14 days

• Average Post-treatment Plasma Level of Erlotinib Hydrochloride

  After last dose of Tarceva, at 5-14 days, and before surgery

Study Arms (1)

Tarceva

EXPERIMENTAL

Drug: erlotinib hydrochloride; Genetic: TUNEL 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 mass spectrometry; Procedure: therapeutic conventional surgery

Interventions

erlotinib hydrochloride DRUG

Tarceva will be given orally at a dose of 150 mg/day for 5-14 days. Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.

Also known as: OSI-774, erlotonib

Tarceva

TUNEL assay GENETIC

Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens

Tarceva

protein expression analysis GENETIC

Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens

Tarceva

immunohistochemistry staining method OTHER

Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens

Tarceva

laboratory biomarker analysis OTHER

Used to assess level of expression of genetic markers in pre-therapy and surgical specimens

Tarceva

liquid chromatography OTHER

Used to determine blood plasma levels of Erlotinib on the day of surgery

Also known as: (LC/MS)

Tarceva

mass spectrometry OTHER

Used to determine blood plasma levels of Erlotinib on the day of surgery

Also known as: (LC/MS)

Tarceva

matrix-assisted laser desorption ionization mass spectrometry OTHER

After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue

Also known as: MALDI MS

Tarceva

therapeutic conventional surgery PROCEDURE

Surgical treatment will occur within 24-hours following completion of therapy.

Tarceva

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

University of Alabama, Birmingham

Birmingham, Alabama, 35249, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27514, United States

Location

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Erlotinib Hydrochloride; Immunohistochemistry; Chromatography, Liquid; Liquid Chromatography-Mass Spectrometry; Mass Spectrometry; Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Chromatography; Chemistry Techniques, Analytical

Results Point of Contact

• Title: Carlos Arteaga, M.D.
• Organization: Vanderbilt-Ingram Cancer Center

(615) 936-1919

Study Officials

• Carlos L. Arteaga, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Cancer Biology, Associate Director of Clinical Research, Director VICC Breast Program, Medical Oncologist

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 12, 2008
• Study Start: August 1, 2002
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: September 5, 2012
• Results First Posted: September 5, 2012

Record last verified: 2012-07

Locations

US (5)