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

Completed

• Conditions: Breast Cancer Female

• Registration Number: NCT03087409
• Lead Sponsor: University Medical Center Groningen

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-22
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 885

Inclusion Criteria

• Enrolment in the original trial.

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Exclusion Criteria

• None.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	2 years	Overall survival according to the definition and analysis plan of the original study
Relapse-free survival	2 years	Relapse-free survival according to the definition and analysis plan of the original study

Secondary Outcome Measures

Name	Time	Method
Incidence of cardiovascular events	2 years
Incidence of malignancies	2 years

Trial Locations

Locations (10)

The Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands

VU University Medical Center; 🇳🇱 Amsterdam, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands