Trial · NCT00503841
Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer
NCT00503841, Not applicable, Terminated, Barbara Ann Karmanos Cancer Institute; results first posted 2013-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer. Trials, record NCT00503841. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00503841
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer
- NCT number
- NCT00503841
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 44 participants, actual
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Conditions
- Breast Cancer
- Interventions
- erlotinib hydrochloride, immunohistochemistry staining method, laboratory biomarker analysis, biopsy, conventional surgery, neoadjuvant therapy
- First posted
- 2007-07-19
- Last updated
- 2019-04-30
- Results first posted
- 2013-02-12
- Limitations and caveats
- All 44 participants that signed consent were screen failures.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect of Erlotinib Hydrochloride on Expression of IL-1a in Patients With ER- Negative, EGFR- Positive and (IL-)1a-positive Breast Cancer | Baseline and day 0 | |
| Secondary | Effect of Erlotinib Hydrochloride on Expression of NF-κB and AR in Patients With ER-negative, EGFR-positive and IL-1a-positive Breast Cancer | Baseline and day 0 | |
| Secondary | Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL) | Baseline and day 0 | |
| Secondary | Toxicity of a 15-day Regimen of Daily Oral Administration of Erlotinib Hydrochloride | At day -7, prior to surgery, and 1 week post-surgery |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effect of Erlotinib Hydrochloride on Expression of IL-1a in Patients With ER- Negative, EGFR- Positive and (IL-)1a-positive Breast Cancer | Baseline and day 0 | No participants received the study drug erlotinib hydrochloride. | ||
| SECONDARY | Effect of Erlotinib Hydrochloride on Expression of NF-κB and AR in Patients With ER-negative, EGFR-positive and IL-1a-positive Breast Cancer | Baseline and day 0 | No data collected for secondary hypotheses. | ||
| SECONDARY | Effect of Erlotinib Hydrochloride on Tumor Cell Proliferation (Ki67) and Apoptosis (TUNEL) | Baseline and day 0 | No data collected for secondary hypotheses. | ||
| SECONDARY | Toxicity of a 15-day Regimen of Daily Oral Administration of Erlotinib Hydrochloride | At day -7, prior to surgery, and 1 week post-surgery | No data collected for secondary hypotheses. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Erlotinib Hydrochloride | 44 | |
| Overall Study | COMPLETED | Erlotinib Hydrochloride | 0 | |
| Overall Study | NOT COMPLETED | Erlotinib Hydrochloride | 44 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erlotinib Hydrochloride | ||
| Total, other adverse events | Erlotinib Hydrochloride | 0 | 0 |
| Total, serious adverse events | Erlotinib Hydrochloride | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA022453 | CANCER CENTER SUPPORT GRANT | PASCHE, BORIS | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00503841
GET https://conductscience.org/api/trials/v1/NCT00503841/registered