Breast CancerNCT00977119
Investigation of Genetic Determinants of Capecitabine Toxicity
An observational study of Breast Cancer, run by University of Chicago at 13 sites in United States.
Trial summary
The purpose of this study is to identify possible genetic polymorphisms that contribute to specific toxicities associated with capecitabine (hand-foot syndrome, diarrhea, and neutropenia). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Side-effect questionnaires and research blood samples
- How many people
- 240 participants
- Where
- 13 sitesUnited States
- Study dates
- 23 Nov 2009to 21 Jun 2021
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving treatment with capecitabine for breast cancer at a participating academic medical center.
Who may be able to join
- women with breast cancer in whom single agent capecitabine therapy is being considered
- aged 18 years and older
Who cannot join
- patients who have previously received capecitabine are excluded
- patients cannot be receiving capecitabine in combination with another cancer chemotherapy; concurrent use of trastuzumab is not permitted; concurrent use of zoledronic acid is allowed
- serum albumin less than 3.0 g/dL within the last 30 days
- creatinine clearance (CrCL) or glomerular filtration rate (GFR) less than 60 mL/min [/body surface area (BSA)] (within the last 30 days)
- inability to understand and give informed consent to participate
- patients with a history of inflammatory bowel disease requiring therapy or patients with chronic diarrhea syndromes or paralytic ileus
Show all 9Show fewer
- patients with prior or concurrent pelvic irradiation
- patients who use an ostomy for fecal excretion
- there is no limit on the number of prior chemotherapies; the decision to use capecitabine is determined solely by the treating physician
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
University of Michigan
Ann Arbor, Michigan, 48109
Johns Hopkins
Baltimore, Maryland, 21205
University of Alabama - Birmingham
Birmingham, Alabama, 35294
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
University of Chicago
Chicago, Illinois, 60637
Duke University
Durham, North Carolina, 27708
NorthShore University HealthSystem
Evanston, Illinois, 60201
Baylor University
Houston, Texas, 77030
M.D. Anderson Cancer Center
Houston, Texas, 77030
Indiana University Cancer Center
Indianapolis, Indiana, 46202
Vanderbilt University Medical Center
Nashville, Tennessee, 73232
Mayo Clinic
Rochester, Minnesota, 55905
Georgetown University
Washington D.C., District of Columbia, 20007
About this study
The purpose of this study is to identify possible genetic polymorphisms that contribute to specific toxicities associated with capecitabine (hand-foot syndrome, diarrhea, and neutropenia).
Additionally, this study will look at gene polymorphisms in patients experiencing the toxicities of interest, the frequency of polymorphisms and differences in drug metabolism.
- Conditions
- Breast Cancer
- Being tested
- Side-effect questionnaires, research blood samples
- Keywords
- breast cancer, capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Side-effect questionnairesOther
Paper or telephone questionnaire to report specific side-effects associated with their breast cancer treatment weekly
research blood samplesOther
Blood samples for research on DNA before starting treatment and after 4 cycles of treatment
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Women with breast cancer receiving capecitabine as treatment for their breast cancer. Receives: Other: Side-effect questionnaires; Other: research blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic variants of toxicity
Measured: 2 years
Secondary outcomes (4)
Time to toxicity based on genetics
Measured: 2 years
Multiple genetic variants as predictors
Measured: 2 years
Genome-wide association (potential)
Measured: 2 years
Correlative sample collection
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 posted15 Sep 2009 (estimated)
- Study start23 Nov 2009
- Primary completion21 Jun 2021
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Breast Cancer Research Consortium, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Peter H O'Donnell, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977119
- Sponsor's protocol ID
- 09-056-B
- Other IDs
- TBCRC 015
- Status last verified
- Jul 2024
- First submitted
- 14 Sep 2009
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Genetic Determinants of Capecitabine Toxicity
- ClinicalTrials.gov ID
- NCT00977119
- Acronym / sponsor ID
- 09-056-B
- Conditions
- Breast Cancer
- Keywords
- breast cancer, capecitabine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Translational Breast Cancer Research Consortium, National Institutes of Health (NIH)
- Study start
- 23 Nov 2009 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 15 Sep 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 purpose of this study is to identify possible genetic polymorphisms that contribute to specific toxicities associated with capecitabine (hand-foot syndrome, diarrhea, and neutropenia).
Additionally, this study will look at gene polymorphisms in patients experiencing the toxicities of interest, the frequency of polymorphisms and differences in drug metabolism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | – | Other: Side-effect questionnaires, Other: research blood samplesWomen with breast cancer receiving capecitabine as treatment for their breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving treatment with capecitabine for breast cancer at a participating academic medical center.
Key inclusion criteria (2 listed)
- women with breast cancer in whom single agent capecitabine therapy is being considered
- aged 18 years and older
Key exclusion criteria (9 listed)
- patients who have previously received capecitabine are excluded
- patients cannot be receiving capecitabine in combination with another cancer chemotherapy; concurrent use of trastuzumab is not permitted; concurrent use of zoledronic acid is allowed
- serum albumin less than 3.0 g/dL within the last 30 days
- creatinine clearance (CrCL) or glomerular filtration rate (GFR) less than 60 mL/min [/body surface area (BSA)] (within the last 30 days)
- inability to understand and give informed consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Side-effect questionnairesPaper or telephone questionnaire to report specific side-effects associated with their breast cancer treatment weekly | Other | Capecitabine |
| research blood samplesBlood samples for research on DNA before starting treatment and after 4 cycles of treatment | Other | Capecitabine |
Primary outcome
Genetic variants of toxicity
Time frame: 2 years
4 secondary outcomes
Time to toxicity based on genetics
Time frame: 2 years
Multiple genetic variants as predictors
Time frame: 2 years
Genome-wide association (potential)
Time frame: 2 years
Correlative sample collection
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 31 Jul 2024.
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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.
Peter H O'Donnell, MD study chair
University of Chicago
13 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, run by University of Chicago at 13 sites in United States.
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 2 inclusion and 9 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 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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?
Genetic variants of toxicity (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2024.