Gene Polymorphisms and Gene Products as Biological Markers of Aging and Correlation With Clinical Geriatric Assessment, Tolerance of Chemotherapy and Outcome in Elderly Breast Cancer Patients
EBS
1 other identifier
observational
110
1 country
2
Brief Summary
The goal is to study the biology of aging in breast cancer patients, and to study the impact of chemotherapy on aging related blood biomarkers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2009
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2009
CompletedFirst Posted
Study publicly available on registry
February 24, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedDecember 9, 2014
December 1, 2014
3.3 years
February 20, 2009
December 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the primary question is whether Chemotherapy affects biological aging markers, such as telomere length and immune status
2 years
Study Arms (2)
1
chemotherapy: elderly patients receiving 4x adjuvant taxotere cyclophosphamide adjuvant for breast cancer
2
adjuvant hormone therapy: 40 patients receiving adjuvant aromatase inhibitor without chemotherapy
Eligibility Criteria
70+, female, M0, all breast tumor types allowed (main goal is effect of chemo on the patient; looking at ER pos only would lead to insufficient numbers). 80 patients receiving adjuvant TC (taxotere cyclophosphamide 75/600) q3w, 4x Nadir systematically in first cycle (d10 and 15) to have idea on haematological toxicity grades III-IV. No primary prophylaxis at first cycle, but allowed for secondary prophylaxis (febrile neutropenia or prolonged neutropenia = 5d \< 500 neutrophils). Herceptin preferably given in HER2 positive patients after chemo (HERA like) in order to have similar treatment; but the investigator can also give concomitantly with chemo. 40 patients receiving 5y AI (control group).
You may qualify if:
- years or older
- Female
- Early breast cancer
- Candidate for systemic adjuvant therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Jules Bordet Institute
Brussels, 1000, Belgium
University Hospitals Leuven
Leuven, 3000, Belgium
Related Publications (2)
Dalmasso B, Hatse S, Brouwers B, Laenen A, Berben L, Kenis C, Smeets A, Neven P, Schoffski P, Wildiers H. Age-related microRNAs in older breast cancer patients: biomarker potential and evolution during adjuvant chemotherapy. BMC Cancer. 2018 Oct 22;18(1):1014. doi: 10.1186/s12885-018-4920-6.
PMID: 30348127DERIVEDBailur JK, Pawelec G, Hatse S, Brouwers B, Smeets A, Neven P, Laenen A, Wildiers H, Shipp C. Immune profiles of elderly breast cancer patients are altered by chemotherapy and relate to clinical frailty. Breast Cancer Res. 2017 Feb 28;19(1):20. doi: 10.1186/s13058-017-0813-x.
PMID: 28241844DERIVED
Biospecimen
peripheral blood is collected for DNA, RNA, serum plasma, and lymphocytes
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- adjunct head of clinic
Study Record Dates
First Submitted
February 20, 2009
First Posted
February 24, 2009
Study Start
May 1, 2009
Primary Completion
September 1, 2012
Study Completion
September 1, 2014
Last Updated
December 9, 2014
Record last verified: 2014-12