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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryThree-year Relapse-free SurvivalFrom 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.
PrimaryFive-year Overall SurvivalFrom 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.

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYThree-year Relapse-free SurvivalFrom date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy.percentage of participantsNUMBER
PRIMARYFive-year Overall SurvivalFrom date of mastectomy until date of death, 5 years post mastectomy.percentage of participantsNUMBER

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Three-year Relapse-free SurvivalNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue61.595% Confidence Interval 30.8 to 81.8percentage of participants
Three-year Relapse-free SurvivalHigh-dose Chemo With Rescue77.895% Confidence Interval 57.1 to 89.3percentage of participants
Five-year Overall SurvivalNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue69.295% Confidence Interval 37.3 to 87.2percentage of participants
Five-year Overall SurvivalHigh-dose Chemo With Rescue70.495% Confidence Interval 49.4 to 83.9percentage of participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue14
Overall StudySTARTEDHigh-dose Chemo With Rescue27
Overall StudyCOMPLETEDNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue14
Overall StudyCOMPLETEDHigh-dose Chemo With Rescue27
Overall StudyNOT COMPLETEDNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue0
Overall StudyNOT COMPLETEDHigh-dose Chemo With Rescue0

Adverse events348

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherCerebellarNervous system disordersNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue4147
otherCerebellarNervous system disordersHigh-dose Chemo With Rescue102719
otherDysrhythmiasCardiac disordersNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue4148
otherDysrhythmiasCardiac disordersHigh-dose Chemo With Rescue92715
otherFluid RetentionRenal and urinary disordersNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue51424
otherFluid RetentionRenal and urinary disordersHigh-dose Chemo With Rescue102726
otherHaematemesisGastrointestinal disordersNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue0140
otherHaematemesisGastrointestinal disordersHigh-dose Chemo With Rescue1271
otherInfectionInfections and infestationsNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue61425
otherInfectionInfections and infestationsHigh-dose Chemo With Rescue112727

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue1014
Total, all-cause mortalityHigh-dose Chemo With Rescue1427
Total, other adverse eventsNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue1314
Total, other adverse eventsHigh-dose Chemo With Rescue2327
Total, serious adverse eventsNeoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue014
Total, serious adverse eventsHigh-dose Chemo With Rescue227

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
P30CA033572Cancer Center Support GrantCARPTEN, JOHN D.BECKMAN RESEARCH INSTITUTE/CITY OF HOPENATIONAL CANCER INSTITUTE1985 to 2025

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue vs High-dose Chemo With Rescue: deaths from any causeTrial comparisons
Neoadjuvant Chemo Followed by Surgery & High-dose Chemo With PSC Rescue vs High-dose Chemo With Rescue: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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