Breast CancerEBSNCT00849758
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
An observational study of Breast Cancer and Elderly, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Cancer, Elderly
- How many people
- 110 participants
- Where
- 2 sitesBelgium
- Study dates
- May 2009to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- No healthy volunteers
- Older adult
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).
Who may be able to join
- 70 years or older
- Female
- Early breast cancer
- Candidate for systemic adjuvant therapy
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Jules Bordet Institute
Brussels, 1000
University Hospitals Leuven
Leuven, 3000
About this study
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 goal is to study the biology of aging in breast cancer patients, and to study the impact of chemotherapy on aging related blood biomarkers.
- Conditions
- Breast Cancer, Elderly
- Keywords
- breast cancer, elderly, biomarker
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
the primary question is whether Chemotherapy affects biological aging markers, such as telomere length and immune status
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2012
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Hans Wildiers, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849758
- Sponsor's protocol ID
- S51518
- Acronym
- EBS
- Status last verified
- Dec 2014
- First submitted
- 20 Feb 2009
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dalmasso B, Hatse S, Brouwers B, Laenen A, Berben L, Kenis C, Smeets A, Neven P, Schoffski P, Wildiers H. Age-related microRNAs in older breast cancer patients: biomarker potential and evolution during adjuvant chemotherapy. BMC Cancer. 2018 Oct 22;18(1):1014. doi: 10.1186/s12885-018-4920-6.
PubMed 30348127Bailur JK, Pawelec G, Hatse S, Brouwers B, Smeets A, Neven P, Laenen A, Wildiers H, Shipp C. Immune profiles of elderly breast cancer patients are altered by chemotherapy and relate to clinical frailty. Breast Cancer Res. 2017 Feb 28;19(1):20. doi: 10.1186/s13058-017-0813-x.
PubMed 28241844
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00849758
- Acronym / sponsor ID
- EBS / S51518
- Conditions
- Breast Cancer, Elderly
- Keywords
- breast cancer, elderly, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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).
Key inclusion criteria (4 listed)
- 70 years or older
- Female
- Early breast cancer
- Candidate for systemic adjuvant therapy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the primary question is whether Chemotherapy affects biological aging markers, such as telomere length and immune status
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Derived from this study: PubMed 30348127Dalmasso B, Hatse S, Brouwers B, Laenen A, Berben L, Kenis C, Smeets A, Neven P, Schoffski P, Wildiers H. Age-related microRNAs in older breast cancer patients: biomarker potential and evolution during adjuvant chemotherapy. BMC Cancer. 2018 Oct 22;18(1):1014. doi: 10.1186/s12885-018-4920-6.
- Derived from this study: PubMed 28241844Bailur JK, Pawelec G, Hatse S, Brouwers B, Smeets A, Neven P, Laenen A, Wildiers H, Shipp C. Immune profiles of elderly breast cancer patients are altered by chemotherapy and relate to clinical frailty. Breast Cancer Res. 2017 Feb 28;19(1):20. doi: 10.1186/s13058-017-0813-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Elderly, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the primary question is whether Chemotherapy affects biological aging markers, such as telomere length and immune status (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00849758, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.