Clinical trial · Interventional
Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery
Phase II Trial of OSI-774 (Tarceva), a Human Epidermal Growth Factor (HER) (erbB, Also Known as Epidermal Growth Factor Receptor, EGFR) Tyrosine Kinase Inhibitor, in Treatment-Naïve Operable Breast Cancer
NCT00633750CI-TRIAL-00007948completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
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 (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| liquid chromatography | Other | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| matrix-assisted laser desorption ionization mass spectrometry | Other | — | UNRESOLVED |
| protein expression analysis | Genetic | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tarceva
- interventionNames
- 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
Primary outcomes (1)
- measure
- Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva
- timeFrame
- 5-14 days
- description
- 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.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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:
* Menopausal status not specified
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* ANC ≥ 1,000/mm\^3
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN
* Serum glutamic oxaloacetic transminase (SGOT) and serum glutamic pyruvic transminase (SGPT) ≤ 1.5 times ULN
* Must be at least 18 years old
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No serious medical illness that, in the judgement of the treating physician, places the patient at high risk of operative mortality
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior chemotherapy for this primary breast cancer
* At least 7 days since prior tamoxifen or raloxifene as a preventive agentReferences
Publications (0)
Data not yet available
No reference posted for this study.