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High-dose Chemotherapy With Hematopoietic Stem-cell Rescue for High-risk Breast Cancer: Long-term Follow-up

High-dose Chemotherapy With Hematopoietic Stem-cell Rescue for High-risk Breast Cancer: Long-term Follow-up of a Randomized Phase III Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03087409
Enrollment
885
Registered
2017-03-22
Start date
2016-07-31
Completion date
2018-07-01
Last updated
2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female

Brief summary

Collection of follow-up data from the original trial patient cohort.

Detailed description

Collection of follow-up data from the original trial patient cohort by means of structured patient file abstraction, a questionnaire to the general practitioner, and registry consultations.

Interventions

None listed

Sponsors

The Netherlands Cancer Institute
CollaboratorOTHER
University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Enrolment in the original trial.

Exclusion criteria

* None.

Design outcomes

Primary

MeasureTime frameDescription
Overall survival2 yearsOverall survival according to the definition and analysis plan of the original study
Relapse-free survival2 yearsRelapse-free survival according to the definition and analysis plan of the original study

Secondary

MeasureTime frame
Incidence of cardiovascular events2 years
Incidence of malignancies2 years

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026