Trial · NCT00179309
Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer
NCT00179309, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-06-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer. Trials, record NCT00179309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00179309
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer
- NCT number
- NCT00179309
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Breast Cancer
- Interventions
- Docetaxel, PANVAC-V, PANVAC-F, Sargramostim
- First posted
- 2005-09-15
- Last updated
- 2014-07-15
- Results first posted
- 2013-06-27
- Limitations and caveats
The goal of this study was to get preliminary evidence of improved progression free survival with the combination compared with docetaxel alone and obtain data on which to plan a larger more definitive study in a more uniform patient population.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | 19.7 months | Time between the first day of treatment and disease progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions. |
| Secondary | Number of Participants With Adverse Events | 80 months | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
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 | Progression-free Survival (PFS) | 19.7 months | Months | MEDIAN | |
| SECONDARY | Number of Participants With Adverse Events | 80 months | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) | Arm I - PANVAC + Docetaxel | 6.6 | 95% Confidence Interval 3.7 to 9.4 | Months | |
| Progression-free Survival (PFS) | Arm II - Docetaxel Alone | 3.8 | 95% Confidence Interval 2.6 to 8.4 | Months | |
| Number of Participants With Adverse Events | Arm I - PANVAC + Docetaxel | 23 | Participants | ||
| Number of Participants With Adverse Events | Arm II - Docetaxel Alone | 23 | Participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment | STARTED | Arm I - PANVAC + Docetaxel | 25 | |
| Treatment | STARTED | Arm II - Docetaxel Alone | 23 | |
| Treatment | COMPLETED | Arm I - PANVAC + Docetaxel | 21 | |
| Treatment | COMPLETED | Arm II - Docetaxel Alone | 18 | |
| Treatment | NOT COMPLETED | Arm I - PANVAC + Docetaxel | 4 | |
| Treatment | NOT COMPLETED | Arm II - Docetaxel Alone | 5 | |
| Crossover | STARTED | Arm I - PANVAC + Docetaxel | 0 | |
| Crossover | STARTED | Arm II - Docetaxel Alone | 3 | |
| Crossover | COMPLETED | Arm I - PANVAC + Docetaxel | 0 | |
| Crossover | COMPLETED | Arm II - Docetaxel Alone | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events342
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 | Fatigue | General disorders | Arm I - PANVAC + Docetaxel | 16 | 25 | 49 |
| other | Fatigue | General disorders | Arm II - Docetaxel Alone | 15 | 23 | 29 |
| other | Anorexia | Gastrointestinal disorders | Arm I - PANVAC + Docetaxel | 5 | 25 | 10 |
| other | Anorexia | Gastrointestinal disorders | Arm II - Docetaxel Alone | 4 | 23 | 5 |
| other | Lymphocyte count decreased | Investigations | Arm I - PANVAC + Docetaxel | 11 | 25 | 49 |
| other | Lymphocyte count decreased | Investigations | Arm II - Docetaxel Alone | 13 | 23 | 41 |
| other | Injection site reaction | Skin and subcutaneous tissue disorders | Arm I - PANVAC + Docetaxel | 17 | 25 | 114 |
| other | Injection site reaction | Skin and subcutaneous tissue disorders | Arm II - Docetaxel Alone | 3 | 23 | 7 |
| other | Alanine aminotransaminase increased | Investigations | Arm I - PANVAC + Docetaxel | 7 | 25 | 15 |
| other | Alanine aminotransaminase increased | Investigations | Arm II - Docetaxel Alone | 9 | 23 | 18 |
1 to 10 of 342Source ClinicalTrials.gov
See all 342 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I - PANVAC + Docetaxel | ||
| Total, all-cause mortality | Arm II - Docetaxel Alone | ||
| Total, other adverse events | Arm I - PANVAC + Docetaxel | 23 | 25 |
| Total, other adverse events | Arm II - Docetaxel Alone | 23 | 23 |
| Total, serious adverse events | Arm I - PANVAC + Docetaxel | 3 | 25 |
| Total, serious adverse events | Arm II - Docetaxel Alone | 2 | 23 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I - PANVAC + Docetaxel vs Arm II - Docetaxel Alone: Number of Participants With Adverse Events | Trial comparisons |
| Arm I - PANVAC + Docetaxel vs Arm II - Docetaxel Alone: serious adverse events | Trial comparisons |
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/NCT00179309
GET https://conductscience.org/api/trials/v1/NCT00179309/events?page=2