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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female

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.

• Study Type: Observational
• Enrollment (Actual): 885

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • VU University Medical Center
  • Amsterdam, Netherlands
    • Academic Medical Center
  • Amsterdam, Netherlands
    • The Netherlands Cancer Institute
  • Enschede, Netherlands
    • Medisch Spectrum Twente
  • Groningen, Netherlands
    • University Medical Center Groningen
  • Leiden, Netherlands
    • Leiden University Medical Center
  • Maastricht, Netherlands
    • Maastricht University Medical Center
  • Nijmegen, Netherlands
    • Radboud University Medical Center
  • Rotterdam, Netherlands
    • Erasmus Medical Center
  • Utrecht, Netherlands
    • University Medical Center Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients with stage II or III breast cancer involving ≥ 4 axillary lymph nodes, who have been treated with adjuvant chemotherapy with or without intensification and hematopoietic stem-cell rescue.

Description

Inclusion Criteria:

• Enrolment in the original trial.

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival according to the definition and analysis plan of the original study	2 years
Relapse-free survival	Relapse-free survival according to the definition and analysis plan of the original study	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of cardiovascular events	2 years
Incidence of malignancies	2 years

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: The Netherlands Cancer Institute
• Investigators: Principal Investigator: J A Gietema, MD, PhD, University Medical Center Groningen; Principal Investigator: G Sonke, MD, PhD, The Netherlands Cancer Institute

Publications and helpful links

General Publications

• 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.
• Steenbruggen TG, Steggink LC, Seynaeve CM, van der Hoeven JJM, Hooning MJ, Jager A, Konings IR, Kroep JR, Smit WM, Tjan-Heijnen VCG, van der Wall E, Bins AD, Linn SC, Schaapveld M, Jacobse JN, van Leeuwen FE, Schroder CP, van Tinteren H, de Vries EGE, Sonke GS, Gietema JA. High-Dose Chemotherapy With Hematopoietic Stem Cell Transplant in Patients With High-Risk Breast Cancer and 4 or More Involved Axillary Lymph Nodes: 20-Year Follow-up of a Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Apr 1;6(4):528-534. doi: 10.1001/jamaoncol.2019.6276.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): October 23, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 201600539

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No