Clinical trial · Interventional
Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer
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
NCT00503841CI-TRIAL-00038392terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): All enrolled participants were screen failures, no data were collected for outcome measures.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- erlotinib hydrochloride
- 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.
- interventionNames
- Drug: erlotinib hydrochloride
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Procedure: biopsy
- Procedure: conventional surgery
- Procedure: neoadjuvant therapy
Primary outcomes (1)
- measure
- Effect of Erlotinib Hydrochloride on Expression of IL-1a in Patients With ER- Negative, EGFR- Positive and (IL-)1a-positive Breast Cancer
- timeFrame
- Baseline and day 0
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 agentsReferences
Publications (0)
Data not yet available
No reference posted for this study.