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:
Information provided by (Responsible Party):
prof. dr. Hans Wildiers, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT00849758
First received: February 20, 2009
Last updated: December 8, 2014
Last verified: December 2014
  Purpose

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.


Condition
Breast Cancer
Elderly

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 ] [ Designated as safety issue: Yes ]

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)
Groups/Cohorts
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

Ages Eligible for Study:   70 Years and older
Genders 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).

Criteria

Inclusion Criteria:

  • 70 years or older
  • Female
  • Early breast cancer
  • Candidate for systemic adjuvant therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849758

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

No publications provided

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

Keywords provided by Universitaire Ziekenhuizen Leuven:
breast cancer
elderly
biomarker

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on March 26, 2015