Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer
This study has been terminated.
(All enrolled participants were screen failures, no data were collected for outcome measures.)
Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborator:
Information provided by (Responsible Party):
Elaina Gartner, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00503841
First received: July 17, 2007
Last updated: March 27, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: erlotinib hydrochloride Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy Procedure: conventional surgery Procedure: neoadjuvant therapy |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Barbara Ann Karmanos Cancer Institute:
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 [ Time Frame: Baseline and day 0 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline and day 0 ] [ Designated as safety issue: No ]
- Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL) [ Time Frame: Baseline and day 0 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 44 |
| Study Start Date: | December 2007 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: erlotinib hydrochloride
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
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.
Other Names:
Other: immunohistochemistry staining method
Assessed at the time of the initial biopsy and at the time of surgery.
Other: laboratory biomarker analysis
Correlative studies
Procedure: biopsy
14 days prior to surgery
Procedure: conventional surgery
14 days after taking study drug erlotinib hydrochloride.
Procedure: neoadjuvant therapy
14 days after taking study drug erlotinib hydrochloride.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503841
Locations
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
| Principal Investigator: | Elaina M. Gartner, MD | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Elaina Gartner, Principal Investigator, Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00503841 History of Changes |
| Obsolete Identifiers: | NCT01654757 |
| Other Study ID Numbers: | CDR0000554965, P30CA022453, WSU-2006-138 |
| Study First Received: | July 17, 2007 |
| Results First Received: | January 9, 2013 |
| Last Updated: | March 27, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
|
stage I breast cancer recurrent breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013