- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00633750
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
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
- Arzneimittel: erlotinib hydrochloride
- Genetisch: TUNEL assay
- Genetisch: protein expression analysis
- Sonstiges: immunohistochemistry staining method
- Sonstiges: laboratory biomarker analysis
- Sonstiges: liquid chromatography
- Sonstiges: mass spectrometry
- Sonstiges: matrix-assisted laser desorption ionization mass spectrometry
- Verfahren: therapeutic conventional surgery
Detaillierte Beschreibung
OBJECTIVES:
Primary
- To determine the in situ antitumor effect of neoadjuvant erlotinib hydrochloride as measured by a reduction in Ki67 and/or an increase in terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate-biotin nick end labeling (TUNEL)-positive tumor cells in patients with treatment-naive, operable breast cancer.
Secondary
- To identify a molecular profile, based on measurements of Estrogen Receptor (ER), Epidermal Growth Factor Receptor (EGFR), and a Human Epithelial Growth Factor Receptor-2(HER2), and protein expression profiles in patients with treatment-naïve, operable breast cancer that is responsive to erlotinib hydrochloride.
- To correlate tumor concentrations of erlotinib hydrochloride with serum levels immediately before surgery.
OUTLINE: This is a multi-center study.
Patients receive oral erlotinib hydrochloride once daily for 5-14 days. Patients then undergo surgical resection within 24 hours after the last dose of erlotinib hydrochloride.
Tumor tissue samples are collected at baseline and during surgery for correlative laboratory studies. Tissue samples are stained for ER, HER2, and EGFR levels, proliferation (Ki67), and apoptosis (TUNEL) by immunohistochemistry. Levels of erlotinib hydrochloride in tissue samples are measured by matrix-assisted laser desorption/ionization mass spectrometry. Blood samples are collected on the day of surgery. Levels of erlotinib hydrochloride in blood samples are measured by liquid chromatography/mass spectrometry.
Patients are followed within 6 weeks after surgery.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 35249
- University of Alabama, Birmingham
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Dana-Farber Cancer Institute
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27514
- Lineberger Comprehensive Cancer Center
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37232
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, Vereinigte Staaten, 37208
- Meharry Medical College
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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 agent
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Tarceva
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Tarceva will be given orally at a dose of 150 mg/day for 5-14 days.
Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
Andere Namen:
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
Used to assess level of expression of genetic markers in pre-therapy and surgical specimens
Used to determine blood plasma levels of Erlotinib on the day of surgery
Andere Namen:
Used to determine blood plasma levels of Erlotinib on the day of surgery
Andere Namen:
After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue
Andere Namen:
Surgical treatment will occur within 24-hours following completion of therapy.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva
Zeitfenster: 5-14 days
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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.
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5-14 days
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Molecular Profile of Participants Who Are Responsive to Tarceva
Zeitfenster: at 5-14 days
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Determined by estrogen receptor status (ER) and human epidermal growth factor receptor 2 (HER2) status, which are measured by staining of 200-500 tumor cells and noting the number stained.
Positive = > 10% of cell show staining, negative = < 10% of cells show staining
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at 5-14 days
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Average Post-treatment Plasma Level of Erlotinib Hydrochloride
Zeitfenster: After last dose of Tarceva, at 5-14 days, and before surgery
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Post-treatment plasma level in µmol/L of erlotinib hydrochloride
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After last dose of Tarceva, at 5-14 days, and before surgery
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienstuhl: Carlos L. Arteaga, MD, Vanderbilt-Ingram Cancer Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- VICC BRE 0222
- P50CA098131 (US NIH Stipendium/Vertrag)
- VU-VICC-BRE-0222
- VU-VICC-020448
- R01CA080195 (US NIH Stipendium/Vertrag)
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