Trial · NCT00429104
Herceptin and GM-CSF for Metastatic Breast Cancer
NCT00429104, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2011-04-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Herceptin and GM-CSF for Metastatic Breast Cancer. Trials, record NCT00429104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00429104
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Herceptin and GM-CSF for Metastatic Breast Cancer
- NCT number
- NCT00429104
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Breast Cancer
- Interventions
- Herceptin, GM-CSF
- First posted
- 2007-01-31
- Last updated
- 2012-12-06
- Results first posted
- 2011-04-15
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Tumor Response (Stable Disease) | 2 months | Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation. |
| Secondary | Duration of Stable Disease | 6 Years | Stable disease is measured from the start of the treatment until the RECIST criteria for disease progression is met. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Tumor Response (Stable Disease) | 2 months | Analysis was per protocol, and of 18 enrolled, one participant was inevaluable. | participants | NUMBER |
| SECONDARY | Duration of Stable Disease | 6 Years | Analysis was per protocol, and of 18 enrolled, one participant was inevaluable. | weeks | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Tumor Response (Stable Disease) | HER2+ Metastatic Breast Cancer | 5 | participants | ||
| Duration of Stable Disease | HER2+ Metastatic Breast Cancer | 15.8 | Full Range 10 to 53.9 | weeks |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HER2+ Metastatic Breast Cancer | 18 | |
| Overall Study | COMPLETED | HER2+ Metastatic Breast Cancer | 17 | |
| Overall Study | NOT COMPLETED | HER2+ Metastatic Breast Cancer | 1 |
Source ClinicalTrials.gov
Adverse events15
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 | Fever | Gastrointestinal disorders | HER2+ Metastatic Breast Cancer | 3 | 17 | |
| other | Nausea | Gastrointestinal disorders | HER2+ Metastatic Breast Cancer | 2 | 17 | |
| other | Vomitting | Gastrointestinal disorders | HER2+ Metastatic Breast Cancer | 1 | 17 | |
| other | Sore Mouth | General disorders | HER2+ Metastatic Breast Cancer | 2 | 17 | |
| other | Diarrhea | Gastrointestinal disorders | HER2+ Metastatic Breast Cancer | 3 | 17 | |
| other | Constipation | Gastrointestinal disorders | HER2+ Metastatic Breast Cancer | 1 | 17 | |
| other | Fatigue | General disorders | HER2+ Metastatic Breast Cancer | 5 | 17 | |
| other | Muscle Pain | Musculoskeletal and connective tissue disorders | HER2+ Metastatic Breast Cancer | 4 | 17 | |
| other | Numbness | Nervous system disorders | HER2+ Metastatic Breast Cancer | 1 | 17 | |
| other | Sore finger/toes | Nervous system disorders | HER2+ Metastatic Breast Cancer | 1 | 17 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HER2+ Metastatic Breast Cancer | ||
| Total, other adverse events | HER2+ Metastatic Breast Cancer | 17 | 17 |
| Total, serious adverse events | HER2+ Metastatic Breast Cancer | 0 | 17 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT00429104
GET https://conductscience.org/api/trials/v1/NCT00429104/registered