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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University Hospital, Gasthuisberg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
stichting tegen kanker
Information provided by:
University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT00849758
First received: February 20, 2009
Last updated: July 2, 2010
Last verified: June 2010

February 20, 2009
July 2, 2010
May 2009
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00849758 on ClinicalTrials.gov Archive Site
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Not Provided
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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
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
Not Provided
Not Provided

Inclusion Criteria:

  • 70 years or older
  • Female
  • Early breast cancer
  • Candidate for systemic adjuvant therapy
Female
70 Years and older
No
Contact: hans wildiers, MD PhD 32 16 346900 hans.wildiers@uzleuven.be
Contact: chantal bernard, MD chantal.bernard@bordet.be
Belgium
 
NCT00849758
S51518
No
university hospitals leuven; wildiers hans
University Hospital, Gasthuisberg
stichting tegen kanker
Not Provided
University Hospital, Gasthuisberg
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP