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NCT03087409 Clinical Trial

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

Breast Cancer Female Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03087409
Other study ID # 201600539
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2016
Est. completion date July 1, 2018

Study information
Verified date May 2024
Source University Medical Center Groningen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 885
Est. completion date July 1, 2018
Est. primary completion date July 1, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Enrolment in the original trial. Exclusion Criteria: - None.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Academic Medical Center Amsterdam
Netherlands The Netherlands Cancer Institute Amsterdam
Netherlands VU University Medical Center Amsterdam
Netherlands Medisch Spectrum Twente Enschede
Netherlands University Medical Center Groningen Groningen
Netherlands Leiden University Medical Center Leiden
Netherlands Maastricht University Medical Center Maastricht
Netherlands Radboud University Medical Center Nijmegen
Netherlands Erasmus Medical Center Rotterdam
Netherlands University Medical Center Utrecht Utrecht

Sponsors (2)
Lead Sponsor Collaborator
University Medical Center Groningen The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Rodenhuis S, Bontenbal M, Beex LV, Wagstaff J, Richel DJ, Nooij MA, Voest EE, Hupperets P, van Tinteren H, Peterse HL, TenVergert EM, de Vries EG; Netherlands Working Party on Autologous Transplantation in Solid Tumors. High-dose chemotherapy with hematopoietic stem-cell rescue for high-risk breast cancer. N Engl J Med. 2003 Jul 3;349(1):7-16. doi: 10.1056/NEJMoa022794. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival Overall survival according to the definition and analysis plan of the original study 2 years
Primary Relapse-free survival Relapse-free survival according to the definition and analysis plan of the original study 2 years
Secondary Incidence of cardiovascular events 2 years
Secondary Incidence of malignancies 2 years
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