Trial · NCT00003042
Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer
NCT00003042, Phase 2, Completed, City of Hope Medical Center; results first posted 2021-04-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer. Trials, record NCT00003042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00003042
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer
- NCT number
- NCT00003042
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Breast Cancer
- Interventions
filgrastim, cisplatin, cyclophosphamide, doxorubicin hydrochloride, melphalan, mesna, paclitaxel, tamoxifen citrate, bone marrow ablation with stem cell support, conventional surgery, peripheral blood stem cell transplantation
- First posted
- 2003-01-27
- Last updated
- 2026-02-20
- Results first posted
- 2021-04-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Three-year Relapse-free Survival | From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy. | Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment. |
| Primary | Five-year Overall Survival | From date of mastectomy until date of death, 5 years post mastectomy. | Estimated using the product-limit method of Kaplan and Meier. Endpoint is defined as death due to any cause. |
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 | Three-year Relapse-free Survival | From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy. | percentage of participants | NUMBER | |
| PRIMARY | Five-year Overall Survival | From date of mastectomy until date of death, 5 years post mastectomy. | percentage of 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 |
|---|---|---|---|---|---|
| Three-year Relapse-free Survival | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 61.5 | 95% Confidence Interval 30.8 to 81.8 | percentage of participants | |
| Three-year Relapse-free Survival | High-dose Chemo With Rescue | 77.8 | 95% Confidence Interval 57.1 to 89.3 | percentage of participants | |
| Five-year Overall Survival | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 69.2 | 95% Confidence Interval 37.3 to 87.2 | percentage of participants | |
| Five-year Overall Survival | High-dose Chemo With Rescue | 70.4 | 95% Confidence Interval 49.4 to 83.9 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 14 | |
| Overall Study | STARTED | High-dose Chemo With Rescue | 27 | |
| Overall Study | COMPLETED | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 14 | |
| Overall Study | COMPLETED | High-dose Chemo With Rescue | 27 | |
| Overall Study | NOT COMPLETED | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 0 | |
| Overall Study | NOT COMPLETED | High-dose Chemo With Rescue | 0 |
Source ClinicalTrials.gov
Adverse events348
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 | Cerebellar | Nervous system disorders | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 4 | 14 | 7 |
| other | Cerebellar | Nervous system disorders | High-dose Chemo With Rescue | 10 | 27 | 19 |
| other | Dysrhythmias | Cardiac disorders | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 4 | 14 | 8 |
| other | Dysrhythmias | Cardiac disorders | High-dose Chemo With Rescue | 9 | 27 | 15 |
| other | Fluid Retention | Renal and urinary disorders | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 5 | 14 | 24 |
| other | Fluid Retention | Renal and urinary disorders | High-dose Chemo With Rescue | 10 | 27 | 26 |
| other | Haematemesis | Gastrointestinal disorders | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 0 | 14 | 0 |
| other | Haematemesis | Gastrointestinal disorders | High-dose Chemo With Rescue | 1 | 27 | 1 |
| other | Infection | Infections and infestations | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 6 | 14 | 25 |
| other | Infection | Infections and infestations | High-dose Chemo With Rescue | 11 | 27 | 27 |
1 to 10 of 348Source ClinicalTrials.gov
See all 348 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 10 | 14 |
| Total, all-cause mortality | High-dose Chemo With Rescue | 14 | 27 |
| Total, other adverse events | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 13 | 14 |
| Total, other adverse events | High-dose Chemo With Rescue | 23 | 27 |
| Total, serious adverse events | Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue | 0 | 14 |
| Total, serious adverse events | High-dose Chemo With Rescue | 2 | 27 |
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 |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue vs High-dose Chemo With Rescue: deaths from any cause | Trial comparisons |
| Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue vs High-dose Chemo With Rescue: 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/NCT00003042
GET https://conductscience.org/api/trials/v1/NCT00003042/events?page=2