Trial · NCT00232505
Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer
NCT00232505, Phase 2, Completed, UNC Lineberger Comprehensive Cancer Center; results first posted 2017-06-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer. Trials, record NCT00232505. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00232505
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer
- NCT number
- NCT00232505
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 112 participants, actual
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Conditions
- Breast Cancer
- Interventions
- cetuximab, carboplatin
- First posted
- 2005-10-04
- Last updated
- 2017-06-28
- Results first posted
- 2017-06-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Disease Response Rate | 5 years | Overall response rate of single agent cetuximab and cetuximab + carboplatin will be measured by radiographic response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria every 8 weeks until subject experiences disease progression. Overall response will be measured as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).Per RECIST v1.0 for target lesions and assessed by CT (spiral): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression |
| Secondary | Overall Survival | Every four months until death of any cause or end of data collection up to 40 months | Subjects will be contacted every 4 months after discontinuation of active treatment to assess survival. |
| Secondary | Progression-Free Survival | Every four months until progression, death of any cause, or end of data collection up to 40 months | Time to disease progression of cetuximab or cetuximab + carboplatin as indicated by radiographic assessment |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Disease Response Rate | 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Every four months until death of any cause or end of data collection up to 40 months | participants surviving | NUMBER | |
| SECONDARY | Progression-Free Survival | Every four months until progression, death of any cause, or end of data collection up to 40 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Disease Response Rate | Cetuximab | Complete response | 0 | Participants | |
| Overall Disease Response Rate | Cetuximab and Carboplatin After Cetuximab Alone | Complete response | 0 | Participants | |
| Overall Disease Response Rate | Cetuximab and Carboplatin | Complete response | 1 | Participants | |
| Overall Disease Response Rate | Cetuximab and Carboplatin Subset | Complete response | 1 | Participants | |
| Overall Disease Response Rate | Cetuximab | Partial response | 2 | Participants | |
| Overall Disease Response Rate | Cetuximab and Carboplatin After Cetuximab Alone | Partial response | 4 | Participants | |
| Overall Disease Response Rate | Cetuximab and Carboplatin | Partial response | 11 | Participants | |
| Overall Disease Response Rate | Cetuximab and Carboplatin Subset | Partial response | 17 | Participants | |
| Overall Disease Response Rate | Cetuximab | Stable disease | 3 | Participants | |
| Overall Disease Response Rate | Cetuximab and Carboplatin After Cetuximab Alone | Stable disease | 7 | Participants |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cetuximab | 31 | |
| Overall Study | STARTED | Cetuximab and Carboplatin | 71 | |
| Overall Study | Not Evaluable | Cetuximab | 0 | |
| Overall Study | Not Evaluable | Cetuximab and Carboplatin | 6 | |
| Overall Study | Early Progressors | Cetuximab | 2 | |
| Overall Study | Early Progressors | Cetuximab and Carboplatin | 5 | |
| Overall Study | Off Protocol | Cetuximab | 5 | |
| Overall Study | Off Protocol | Cetuximab and Carboplatin | 0 | |
| Overall Study | COMPLETED | Cetuximab | 26 | |
| Overall Study | COMPLETED | Cetuximab and Carboplatin | 60 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events474
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Cetuximab | 0 | 31 | |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Cetuximab and Carboplatin After Cetuximab Alone | 1 | 25 | |
| other | Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | Cetuximab and Carboplatin | 3 | 71 | |
| other | Alkaline phosphatase | Investigations | Cetuximab | 6 | 31 | |
| other | Alkaline phosphatase | Investigations | Cetuximab and Carboplatin After Cetuximab Alone | 6 | 25 | |
| other | Alkaline phosphatase | Investigations | Cetuximab and Carboplatin | 9 | 71 | |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Cetuximab | 1 | 31 | |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Cetuximab and Carboplatin After Cetuximab Alone | 0 | 25 | |
| other | Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Cetuximab and Carboplatin | 5 | 71 | |
| other | Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | Cetuximab | 1 | 31 |
1 to 10 of 474Source ClinicalTrials.gov
See all 474 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cetuximab | ||
| Total, all-cause mortality | Cetuximab and Carboplatin After Cetuximab Alone | ||
| Total, all-cause mortality | Cetuximab and Carboplatin | ||
| Total, other adverse events | Cetuximab | 27 | 31 |
| Total, other adverse events | Cetuximab and Carboplatin After Cetuximab Alone | 24 | 25 |
| Total, other adverse events | Cetuximab and Carboplatin | 68 | 71 |
| Total, serious adverse events | Cetuximab | 3 | 31 |
| Total, serious adverse events | Cetuximab and Carboplatin After Cetuximab Alone | 8 | 25 |
| Total, serious adverse events | Cetuximab and Carboplatin | 20 | 71 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| M01RR000046 | General Clinical Research Center | ORRINGER, EUGENE P | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL CENTER FOR RESEARCH RESOURCES | 1985 to 2008 |
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/NCT00232505
GET https://conductscience.org/api/trials/v1/NCT00232505/results?page=2