Breast CancerNCT00503841
Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer
A study testing erlotinib hydrochloride, immunohistochemistry staining method and laboratory biomarker analysis in people with Breast Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- erlotinib hydrochloride, immunohistochemistry staining method and laboratory biomarker 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
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to May 2010
- Phase
- Interventional
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 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
Who cannot join
- Locally advanced or metastatic disease not amenable to surgery
- Known brain metastases
- PATIENT CHARACTERISTICS:
- 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:
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- 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:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- erlotinib hydrochloride, immunohistochemistry staining method, laboratory biomarker analysis, biopsy, conventional surgery
- Keywords
- stage I breast cancer, recurrent breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC 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 CP-358,774, Erlotinib, OSI-774, Tarceva
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.
immunohistochemistry staining methodOther
Assessed at the time of the initial biopsy and at the time of surgery.
laboratory biomarker analysisOther
Correlative studies
biopsyProcedure or surgery
14 days prior to surgery
conventional surgeryProcedure or surgery
14 days after taking study drug erlotinib hydrochloride.
neoadjuvant therapyProcedure or surgery
14 days after taking study drug erlotinib hydrochloride.
| Study group | Role | What they receive |
|---|---|---|
| erlotinib hydrochloride | Experimental | 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. Receives: Drug: erlotinib hydrochloride; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Procedure: biopsy; Procedure: conventional surgery; Procedure: neoadjuvant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Erlotinib Hydrochloride on Expression of IL-1a in Patients With ER- Negative, EGFR- Positive and (IL-)1a-positive Breast Cancer
Measured: Baseline and day 0
Secondary outcomes (3)
Effect of Erlotinib Hydrochloride on Expression of NF-κB and AR in Patients With ER-negative, EGFR-positive and IL-1a-positive Breast Cancer
Measured: Baseline and day 0
Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL)
Measured: Baseline and day 0
Toxicity of a 15-day Regimen of Daily Oral Administration of Erlotinib Hydrochloride
Measured: At day -7, prior to surgery, and 1 week post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startDec 2007
- Primary completionFeb 2010
- Study completionMay 2010
Why it stopped: All enrolled participants were screen failures, no data were collected for outcome measures.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Elaina Gartner, Barbara Ann Karmanos Cancer Institute
- Investigators
- Elaina M. Gartner, MD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503841
- Sponsor's protocol ID
- CDR0000554965
- Other IDs
- P30CA022453, WSU-2006-138
- Status last verified
- Apr 2019
- First submitted
- 17 Jul 2007
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00503841
- Acronym / sponsor ID
- CDR0000554965
- Conditions
- Breast Cancer
- Keywords
- stage I breast cancer, recurrent breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All enrolled participants were screen failures, no data were collected for outcome measures.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Posted 12 Feb 2013
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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| erlotinib hydrochloride | Experimental | Drug: erlotinib hydrochloride, Other: immunohistochemistry staining method, Other: laboratory biomarker analysis, Procedure: biopsy, Procedure: conventional surgery, Procedure: neoadjuvant therapyPatients 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Cytologically or histologically confirmed adenocarcinoma of the breast
- 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)
- Female
- Menopausal status not specified
Key exclusion criteria (15 listed)
- Locally advanced or metastatic disease not amenable to surgery
- Known brain metastases
- 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:
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: CP-358,774, Erlotinib, OSI-774, TarcevaPatients 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 |
| immunohistochemistry staining methodAssessed at the time of the initial biopsy and at the time of surgery. | Other | erlotinib hydrochloride |
| laboratory biomarker analysisCorrelative studies | Other | erlotinib hydrochloride |
| biopsy14 days prior to surgery | Procedure or surgery | erlotinib hydrochloride |
| conventional surgery14 days after taking study drug erlotinib hydrochloride. | Procedure or surgery | erlotinib hydrochloride |
| neoadjuvant therapy14 days after taking study drug erlotinib hydrochloride. | Procedure or surgery | erlotinib hydrochloride |
Primary outcome
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
3 secondary outcomes
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
Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL)
Time frame: Baseline and day 0
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink provided by the sponsor.
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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.
Elaina M. Gartner, MD principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erlotinib hydrochloride, immunohistochemistry staining method and laboratory biomarker analysis in people with Breast Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site 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 21 inclusion and 15 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: stopped early, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2013). 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?
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). 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 30 Apr 2019.