Breast CancerNCT00953537
Predicting Response to Capecitabine in Women With Metastatic Breast Cancer
A study testing capecitabine, laboratory biomarker analysis and pharmacological study in people with Breast Cancer, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
RATIONALE: Identifying genes that increase a person's susceptibility to side effects caused by capecitabine may help doctors plan better treatment. PURPOSE: This clinical trial is studying blood samples in predicting response to capecitabine in women with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- capecitabine, laboratory biomarker analysis and pharmacological study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Feb 2011
- Phase
- Interventional
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Radiologically (by scintography) or histologically confirmed metastatic breast cancer
- At least 1 measurable or evaluable target lesion
- Receiving capecitabine as monotherapy or with targeted antiangiogenic therapies (e.g., bevacizumab or trastuzumab)
- No uncontrolled brain metastases
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Life expectancy ≥ 3 months
- Fertile patients must use effective contraception
- No chronic uncontrolled illness
- No congestive heart failure
- No peripheral venous disease
- No severe uncontrolled infection
- No hypoxemic respiratory failure
- No prior primary cancer except for basal cell carcinoma of the skin
- No psychologic disorder
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No capecitabine co-administered with chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Pilot Study of Dihydropyrimidine Dehydrogenase (DPD) Deficiency for Predicting Capecitabine Toxicity in Breast Cancer Patients
RATIONALE: Identifying genes that increase a person's susceptibility to side effects caused by capecitabine may help doctors plan better treatment.
PURPOSE: This clinical trial is studying blood samples in predicting response to capecitabine in women with metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the sensitivity, specificity, and positive and negative predictive values of dihydrouracil/uracil (UH_2/U) ratio measured before starting treatment on grade 3-4 capecitabine-related toxicity in women with metastatic breast cancer.
Secondary
- To prospectively test the value of the germinal genotype of thymidylate synthase (TS) and methylenetetrahydrofolate reductase (MTHFR) as predictors of resistance to capecitabine.
- To evaluate the practical feasibility of such pre-therapeutic screening.
- To determine the sensitivity, specificity, and positive and negative predictive values of dihydropyrimidine dehydrogenase genotyping on grade 3-4 capecitabine-related toxicity in the first and second courses.
- To evaluate the predictive gain provided by genotyping relative to phenotyping alone.
- To evaluate the influence of TS and MTHFR gene polymorphisms on clinical response and duration of response.
- To evaluate the pharmacokinetics of capecitabine and its metabolites and their relationship with UH_2/U and genotype.
- To evaluate the total cost of pre-therapeutic phenotyping alone and the combination of phenotyping and genotyping.
- To exhaustively analyze the 23 exons of the dihydropyrimidine dehydrogenase (DPYD) gene in patients who developed toxicity.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected 8-15 days before the start of treatment and periodically on the first day of treatment for dihydropyrimidine dehydrogenase phenotyping (dihydrouracil/uracil ratio and high performance liquid chromatography analysis), genotyping (4 most relevant single nucleotide polymorphisms), and pharmacokinetic analysis.
- Conditions
- Breast Cancer
- Being tested
- capecitabine, laboratory biomarker analysis, pharmacological study
- Keywords
- stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| capecitabine | Other | Not described Receives: Drug: capecitabine; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capecitabine-related toxicity (i.e., hematological, diarrhea, and hand-foot syndrome) recorded during the first and second courses
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Marc Ferrero, MD, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953537
- Sponsor's protocol ID
- CDR0000638377
- Other IDs
- CALACASS-DPD-Sein, 2008/21, INCA-RECF0942, EUDRACT-2008-004136-20
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2009
- Last updated
- 5 May 2026
- Results posted
- No
Publications
Etienne-Grimaldi MC, Boyer JC, Beroud C, Mbatchi L, van Kuilenburg A, Bobin-Dubigeon C, Thomas F, Chatelut E, Merlin JL, Pinguet F, Ferrand C, Meijer J, Evrard A, Llorca L, Romieu G, Follana P, Bachelot T, Chaigneau L, Pivot X, Dieras V, Largillier R, Mousseau M, Goncalves A, Roche H, Bonneterre J, Servent V, Dohollou N, Chateau Y, Chamorey E, Desvignes JP, Salgado D, Ferrero JM, Milano G. New advances in DPYD genotype and risk of severe toxicity under capecitabine. PLoS One. 2017 May 8;12(5):e0175998. doi: 10.1371/journal.pone.0175998. eCollection 2017.
PubMed 28481884
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Pilot Study of Dihydropyrimidine Dehydrogenase (DPD) Deficiency for Predicting Capecitabine Toxicity in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00953537
- Acronym / sponsor ID
- CDR0000638377
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 6 Aug 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.
RATIONALE: Identifying genes that increase a person's susceptibility to side effects caused by capecitabine may help doctors plan better treatment.
PURPOSE: This clinical trial is studying blood samples in predicting response to capecitabine in women with metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the sensitivity, specificity, and positive and negative predictive values of dihydrouracil/uracil (UH_2/U) ratio measured before starting treatment on grade 3-4 capecitabine-related toxicity in women with metastatic breast cancer.
Secondary
- To prospectively test the value of the germinal genotype of thymidylate synthase (TS) and methylenetetrahydrofolate reductase (MTHFR) as predictors of resistance to capecitabine.
- To evaluate the practical feasibility of such pre-therapeutic screening.
- To determine the sensitivity, specificity, and positive and negative predictive values of dihydropyrimidine dehydrogenase genotyping on grade 3-4 capecitabine-related toxicity in the first and second courses.
- To evaluate the predictive gain provided by genotyping relative to phenotyping alone.
- To evaluate the influence of TS and MTHFR gene polymorphisms on clinical response and duration of response.
- To evaluate the pharmacokinetics of capecitabine and its metabolites and their relationship with UH_2/U and genotype.
- To evaluate the total cost of pre-therapeutic phenotyping alone and the combination of phenotyping and genotyping.
- To exhaustively analyze the 23 exons of the dihydropyrimidine dehydrogenase (DPYD) gene in patients who developed toxicity.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Blood samples are collected 8-15 days before the start of treatment and periodically on the first day of treatment for dihydropyrimidine dehydrogenase phenotyping (dihydrouracil/uracil ratio and high performance liquid chromatography analysis), genotyping (4 most relevant single nucleotide polymorphisms), and pharmacokinetic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capecitabine | Other | Drug: capecitabine, Other: laboratory biomarker analysis, Other: pharmacological study |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| capecitabine | Drug | capecitabine |
| laboratory biomarker analysis | Other | capecitabine |
| pharmacological study | Other | capecitabine |
Primary outcome
Capecitabine-related toxicity (i.e., hematological, diarrhea, and hand-foot syndrome) recorded during the first and second courses
Time frame: 3 months
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 5 May 2026.
- Results publication: PubMed 28481884Etienne-Grimaldi MC, Boyer JC, Beroud C, Mbatchi L, van Kuilenburg A, Bobin-Dubigeon C, Thomas F, Chatelut E, Merlin JL, Pinguet F, Ferrand C, Meijer J, Evrard A, Llorca L, Romieu G, Follana P, Bachelot T, Chaigneau L, Pivot X, Dieras V, Largillier R, Mousseau M, Goncalves A, Roche H, Bonneterre J, Servent V, Dohollou N, Chateau Y, Chamorey E, Desvignes JP, Salgado D, Ferrero JM, Milano G. New advances in DPYD genotype and risk of severe toxicity under capecitabine. PLoS One. 2017 May 8;12(5):e0175998. doi: 10.1371/journal.pone.0175998. eCollection 2017.
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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.
Jean Marc Ferrero, MD principal investigator
Centre Antoine Lacassagne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capecitabine, laboratory biomarker analysis and pharmacological study in people with Breast Cancer, run by Centre Antoine Lacassagne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Capecitabine-related toxicity (i.e., hematological, diarrhea, and hand-foot syndrome) recorded during the first and second courses (time frame: 3 months). 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 NCT00953537, which also lists 1 linked publication.
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 5 May 2026.