Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer

NCT00503841 | Terminated Results DMC

• 3 other identifiers: CDR0000554965P30CA022453WSU-2006-138
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This clinical trial is studying how well erlotinib works in treating women undergoing surgery for stage I, stage II, or stage III breast cancer.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Effect of Erlotinib Hydrochloride on Expression of IL-1a in Patients With ER- Negative, EGFR- Positive and (IL-)1a-positive Breast Cancer

  Baseline and day 0

Secondary Outcomes (3)

• Effect of Erlotinib Hydrochloride on Expression of NF-κB and AR in Patients With ER-negative, EGFR-positive and IL-1a-positive Breast Cancer

  Baseline and day 0

• Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL)

  Baseline and day 0

• Toxicity of a 15-day Regimen of Daily Oral Administration of Erlotinib Hydrochloride

  At day -7, prior to surgery, and 1 week post-surgery

Study Arms (1)

erlotinib hydrochloride

EXPERIMENTAL

Patients receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.

Drug: erlotinib hydrochloride; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: biopsy; Procedure: conventional surgery; Procedure: neoadjuvant therapy

Interventions

erlotinib hydrochloride DRUG

Patients receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.

Also known as: CP-358,774, Erlotinib, OSI-774, Tarceva

erlotinib hydrochloride

immunohistochemistry staining method OTHER

Assessed at the time of the initial biopsy and at the time of surgery.

erlotinib hydrochloride

laboratory biomarker analysis OTHER

Correlative studies

erlotinib hydrochloride

biopsy PROCEDURE

14 days prior to surgery

erlotinib hydrochloride

conventional surgery PROCEDURE

14 days after taking study drug erlotinib hydrochloride.

erlotinib hydrochloride

neoadjuvant therapy PROCEDURE

14 days after taking study drug erlotinib hydrochloride.

erlotinib hydrochloride

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cytologically or histologically confirmed adenocarcinoma of the breast
• Stage I-III disease
• BI-RADS 4 or 5 abnormalities on breast imaging and undergoing core needle biopsy for diagnosis
• Participants must have a lesion of at least 1-cm on breast imaging studies (mammogram, ultrasound, or MRI)
• Participants must have breast cancer amenable to surgery with curative intent and must have agreed to undergo such surgery
• The surgical procedure must be scheduled in the near future to accommodate a treatment period of no less and no more than 15 days
• Clinically positive for the overexpression of EGFR and interleukin-1α
• Clinically negative for expression of the estrogen receptor (ER-negative) and progesterone receptor (PgR-negative)
• May be positive or negative for HER2

You may not qualify if:

• Locally advanced or metastatic disease not amenable to surgery
• Known brain metastases
• PATIENT CHARACTERISTICS:
• Female
• Menopausal status not specified
• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
• ANC ≥ 1000/mm³
• Platelet count ≥ 75,000/mm³
• AST and ALT ≤ 2.5 times upper limits of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Bilirubin ≤ 2 times ULN
• Hemoglobin \> 9 g/dL
• Creatinine within normal institutional limits OR creatinine clearance \>60 mL/min
• Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and women within 6 months of menopause
• Women of child-bearing potential and their partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Erlotinib Hydrochloride; Immunohistochemistry; Biopsy; Neoadjuvant Therapy

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; Cytodiagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Combined Modality Therapy; Therapeutics

Limitations and Caveats

All 44 participants that signed consent were screen failures.

Results Point of Contact

• Title: Dr. Elaina Gartner
• Organization: Barbara Ann Karmanos Cancer Institute

egartner@seagen.com

313-576-8724

Study Officials

• Elaina M. Gartner, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 19, 2007
• Study Start: December 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 30, 2019
• Results First Posted: February 12, 2013

Record last verified: 2019-04

Locations

US (1)