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)
This study has been completed.
Information provided by (Responsible Party):
prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven
First received: February 20, 2009
Last updated: December 8, 2014
Last verified: December 2014
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.
||Observational Model: Case Control
Time Perspective: Prospective
||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.
Biospecimen Retention: Samples With DNA
Primary Outcome Measures:
- the primary question is whether Chemotherapy affects biological aging markers, such as telomere length and immune status [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
peripheral blood is collected for DNA, RNA, serum plasma, and lymphocytes
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2012 (Final data collection date for primary outcome measure)
chemotherapy: elderly patients receiving 4x adjuvant taxotere cyclophosphamide adjuvant for breast cancer
adjuvant hormone therapy: 40 patients receiving adjuvant aromatase inhibitor without chemotherapy
|Ages Eligible for Study:
||70 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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).
- 70 years or older
- Early breast cancer
- Candidate for systemic adjuvant therapy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00849758
|Jules Bordet Institute
|Brussels, Belgium, 1000 |
|University Hospitals Leuven
|Leuven, Belgium, 3000 |
Universitaire Ziekenhuizen Leuven
No publications provided
||prof. dr. Hans Wildiers, adjunct head of clinic, Universitaire Ziekenhuizen Leuven
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 20, 2009
||December 8, 2014
||Belgium: Institutional Review Board
Keywords provided by Universitaire Ziekenhuizen Leuven:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 28, 2015
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