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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.
Information provided by (Responsible Party):
prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven Identifier:
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.

Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • the primary question is whether Chemotherapy affects biological aging markers, such as telomere length and immune status [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
peripheral blood is collected for DNA, RNA, serum plasma, and lymphocytes

Enrollment: 110
Study Start Date: May 2009
Study Completion Date: September 2014
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   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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).


Inclusion Criteria:

  • 70 years or older
  • Female
  • Early breast cancer
  • Candidate for systemic adjuvant therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00849758

Jules Bordet Institute
Brussels, Belgium, 1000
University Hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  More Information

Responsible Party: prof. dr. Hans Wildiers, adjunct head of clinic, Universitaire Ziekenhuizen Leuven Identifier: NCT00849758     History of Changes
Other Study ID Numbers: S51518
Study First Received: February 20, 2009
Last Updated: December 8, 2014

Keywords provided by Universitaire Ziekenhuizen Leuven:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on April 21, 2017