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

NCT03087409 | Completed

• 1 other identifier: 201600539
• Study Type: observational
• Target: 885
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Incidence of cardiovascular events

  2 years

• Incidence of malignancies

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Enrolment in the original trial.

You may not qualify if:

• None.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• The Netherlands Cancer Institute: collaborator

Study Sites (10)

Academic Medical Center

Amsterdam, Netherlands

Location

The Netherlands Cancer Institute

Amsterdam, Netherlands

Location

VU University Medical Center

Amsterdam, Netherlands

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Maastricht University Medical Center

Maastricht, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 12840087 BACKGROUND

• 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.

  PMID: 31999296 DERIVED

Study Officials

• J A Gietema, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

• G Sonke, MD, PhD

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 22, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (10)