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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
erlotinib hydrochloride
immunohistochemistry staining method
laboratory biomarker analysis
biopsy
conventional surgery
neoadjuvant therapy
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage I breast cancer, recurrent breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Inclusion

  • 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

Exclusion

  • Locally advanced or metastatic disease not amenable to surgery
  • Known brain metastases

PATIENT CHARACTERISTICS:

Inclusion

  • 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

Exclusion

  • Pregnant or nursing
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride

  • Uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness/social situations that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

Exclusion

  • Received any other therapy (i.e., surgery, radiation, hormone treatment, biologic therapy, and/or chemotherapy) for the treatment of breast cancer
  • Concurrent use of anti-neoplastic or anti-tumor agents not part of the study therapy, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy
  • Receiving any other investigational agents

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

erlotinib hydrochloride

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect of Erlotinib Hydrochloride on Expression of NF-κB and AR in Patients With ER-negative, EGFR-positive and IL-1a-positive Breast Cancer
Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL)
Toxicity of a 15-day Regimen of Daily Oral Administration of Erlotinib Hydrochloride

Full Information

First Posted
July 17, 2007
Last Updated
April 22, 2019
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00503841
Brief Title
Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer
Official Title
A Pilot Study of the Effect of Erlotinib (Tarceva®) on Biomarkers in Estrogen Receptor Negative Breast Cancer Expressing the Epidermal Growth Factor Receptor and Interleukin 1α
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
All enrolled participants were screen failures, no data were collected for outcome measures.
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary To estimate the effect of erlotinib hydrochloride on expression of interleukin (IL)-1α in patients with estrogen receptor (ER-)-negative, EGFR-positive and IL-1α-positive breast cancer. Secondary To estimate the effect of erlotinib hydrochloride on expression of nuclear NF-κB and amphiregulin (AR) in patients with ER-negative, EGFR-positive and IL-1α-positive breast cancer. To estimate the effect of erlotinib on tumor cell proliferation (Ki67) and apoptosis (TUNEL). To estimate the rates of IL-1α, nuclear NF-κB, and AR expression in patients with ER-negative, EGFR-positive breast cancer. To follow the clinical course of patients with resectable ER-negative, EGFR-positive and IL-1α-positive breast cancer. To assess the toxicity of a 15-day regimen of daily oral administration of erlotinib hydrochloride in participants with ER-negative, EGFR-positive and IL-1α-positive breast cancer. OUTLINE: This is an open-label, pilot study. Patients are stratified according to HER2 status (positive vs negative). Patients receive oral erlotinib hydrochloride once daily on days -14 to 0 in the absence of disease progression or unacceptable toxicity. Patients undergo surgery on day 0. Tissue samples are collected at baseline and examined for expression of estrogen receptor, progesterone receptor, HER2, EGFR, interleukin (IL)-1α, amphiregulin, and NF-kB. Tissue samples collected at surgery are examined for IL-1α, NF-kB, and amphiregulin by IHC. Following surgery, patients will be contacted 1 week post-surgery (± 1 day) or 1 week post-withdrawal from study (± 1 day) by phone call or clinic visit to assess toxicity. After that, patients will be followed and treated according to standard of care practices. If patients choose to follow-up with an oncologist outside of our institution, they or their oncologist will be contacted every 6 months for updated information on their conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
erlotinib hydrochloride
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
erlotinib hydrochloride
Other Intervention Name(s)
CP-358,774, Erlotinib, OSI-774, Tarceva
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Description
Assessed at the time of the initial biopsy and at the time of surgery.
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Description
14 days prior to surgery
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
14 days after taking study drug erlotinib hydrochloride.
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Description
14 days after taking study drug erlotinib hydrochloride.
Primary Outcome Measure Information:
Title
Effect of Erlotinib Hydrochloride on Expression of IL-1a in Patients With ER- Negative, EGFR- Positive and (IL-)1a-positive Breast Cancer
Time Frame
Baseline and day 0
Secondary Outcome Measure Information:
Title
Effect of Erlotinib Hydrochloride on Expression of NF-κB and AR in Patients With ER-negative, EGFR-positive and IL-1a-positive Breast Cancer
Time Frame
Baseline and day 0
Title
Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL)
Time Frame
Baseline and day 0
Title
Toxicity of a 15-day Regimen of Daily Oral Administration of Erlotinib Hydrochloride
Time Frame
At day -7, prior to surgery, and 1 week post-surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Inclusion 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 Exclusion Locally advanced or metastatic disease not amenable to surgery Known brain metastases PATIENT CHARACTERISTICS: Inclusion 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 Exclusion Pregnant or nursing History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride Uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection Symptomatic congestive heart failure Unstable angina pectoris Cardiac arrhythmia Psychiatric illness/social situations that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: Exclusion Received any other therapy (i.e., surgery, radiation, hormone treatment, biologic therapy, and/or chemotherapy) for the treatment of breast cancer Concurrent use of anti-neoplastic or anti-tumor agents not part of the study therapy, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy Receiving any other investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaina M. Gartner, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.gov/clinicaltrials
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

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

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