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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00849758
First Posted: February 24, 2009
Last Update Posted: December 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven
February 20, 2009
February 24, 2009
December 9, 2014
May 2009
September 2012   (Final data collection date for primary outcome measure)
the primary question is whether Chemotherapy affects biological aging markers, such as telomere length and immune status [ Time Frame: 2 years ]
Same as current
Complete list of historical versions of study NCT00849758 on ClinicalTrials.gov Archive Site
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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
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.
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
peripheral blood is collected for DNA, RNA, serum plasma, and lymphocytes
Probability Sample

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).

  • Breast Cancer
  • Elderly
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
September 2014
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 70 years or older
  • Female
  • Early breast cancer
  • Candidate for systemic adjuvant therapy
Sexes Eligible for Study: Female
70 Years and older   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00849758
S51518
No
Not Provided
Not Provided
prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Not Provided
Universitaire Ziekenhuizen Leuven
December 2014