Breast CancerPhase 2NCT00633750
Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery
A Phase 2 study testing erlotinib hydrochloride, TUNEL assay and protein expression analysis in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- erlotinib hydrochloride, TUNEL assay and protein expression analysis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- Aug 2002to Oct 2007
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 30Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama, Birmingham
Birmingham, Alabama, 35249
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
Meharry Medical College
Nashville, Tennessee, 37208
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- erlotinib hydrochloride, TUNEL assay, protein expression analysis, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib hydrochlorideDrug
Also called OSI-774, erlotonib
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.
TUNEL assayGenetic
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
protein expression analysisGenetic
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
immunohistochemistry staining methodOther
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
laboratory biomarker analysisOther
Used to assess level of expression of genetic markers in pre-therapy and surgical specimens
liquid chromatographyOther
Also called (LC/MS)
Used to determine blood plasma levels of Erlotinib on the day of surgery
mass spectrometryOther
Also called (LC/MS)
Used to determine blood plasma levels of Erlotinib on the day of surgery
matrix-assisted laser desorption ionization mass spectrometryOther
Also called MALDI MS
After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue
therapeutic conventional surgeryProcedure or surgery
Surgical treatment will occur within 24-hours following completion of therapy.
| Study group | Role | What they receive |
|---|---|---|
| Tarceva | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva
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.
Measured: 5-14 days
Secondary outcomes (2)
Molecular Profile of Participants Who Are Responsive to Tarceva
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
Measured: at 5-14 days
Average Post-treatment Plasma Level of Erlotinib Hydrochloride
Post-treatment plasma level in µmol/L of erlotinib hydrochloride
Measured: After last dose of Tarceva, at 5-14 days, and before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startAug 2002
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Carlos L. Arteaga, Vanderbilt-Ingram Cancer Center
- Investigators
- Carlos L. Arteaga, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633750
- Sponsor's protocol ID
- VICC BRE 0222
- Other IDs
- VU-VICC-BRE-0222, VU-VICC-020448, P50CA098131, R01CA080195
- Status last verified
- Jul 2012
- First submitted
- 11 Mar 2008
- Last updated
- 5 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00633750
- Acronym / sponsor ID
- VICC BRE 0222
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2002
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Posted 5 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tarceva | Experimental | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma
Key exclusion criteria (30 listed)
- Patients with locally advanced disease who are planning to undergo preoperative neoadjuvant therapy are not eligible*
- Measurable residual tumor at the primary site
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erlotinib hydrochlorideAlso: OSI-774, erlotonibTarceva 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. | Drug | Tarceva |
| TUNEL assayUsed to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens | Genetic | Tarceva |
| protein expression analysisUsed to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens | Genetic | Tarceva |
| immunohistochemistry staining methodUsed to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens | Other | Tarceva |
| laboratory biomarker analysisUsed to assess level of expression of genetic markers in pre-therapy and surgical specimens | Other | Tarceva |
| liquid chromatographyAlso: (LC/MS)Used to determine blood plasma levels of Erlotinib on the day of surgery | Other | Tarceva |
| mass spectrometryAlso: (LC/MS)Used to determine blood plasma levels of Erlotinib on the day of surgery | Other | Tarceva |
| matrix-assisted laser desorption ionization mass spectrometryAlso: MALDI MSAfter treatment and following surgery, intervention will be used to determine Tarceva levels in tissue | Other | Tarceva |
| therapeutic conventional surgerySurgical treatment will occur within 24-hours following completion of therapy. | Procedure or surgery | Tarceva |
Primary outcome
Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva
Time frame: 5-14 days
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.
2 secondary outcomes
Molecular Profile of Participants Who Are Responsive to Tarceva
Time frame: at 5-14 days
Average Post-treatment Plasma Level of Erlotinib Hydrochloride
Time frame: After last dose of Tarceva, at 5-14 days, and before surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos L. Arteaga, MD study chair
Vanderbilt-Ingram Cancer Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing erlotinib hydrochloride, TUNEL assay and protein expression analysis in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva (time frame: 5-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2012.