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)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
- 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
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2009 |
| 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 |
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| Contact: hans wildiers, MD PhD | 32 16 346900 | hans.wildiers@uzleuven.be |
| Contact: chantal bernard, MD | chantal.bernard@bordet.be |
| Belgium | |
| Jules Bordet Institute | Recruiting |
| Brussels, Belgium, 1000 | |
| Contact: chantal bernard | |
| Principal Investigator: chantal bernard, MD | |
| University Hospitals Leuven | Recruiting |
| Leuven, Belgium, 3000 | |
| Contact: hans wildiers | |
| Principal Investigator: hans wildiers, MD PhD | |
More Information
No publications provided
| Responsible Party: | university hospitals leuven; wildiers hans |
| ClinicalTrials.gov Identifier: | NCT00849758 History of Changes |
| Other Study ID Numbers: | S51518 |
| Study First Received: | February 20, 2009 |
| Last Updated: | July 2, 2010 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by University Hospital, Gasthuisberg:
|
breast cancer elderly biomarker |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013