Predicting Response to Capecitabine in Women With Metasta... | NCT00953537

Studies
Predicting Response to Capecitabine in Women With Metastatic Breast Cancer

NCT00953537

Sponsor

Centre Antoine Lacassagne

Status

Completed

Last Update Posted

May 5, 2026Actual

Enrollment

303Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

capecitabine
laboratory biomarker analysis
pharmacological study

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Aug 5, 2009

First Submission Date that Met QC Criteria

Aug 5, 2009

First Posted Date

Aug 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

May 5, 2026Actual

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

303Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
capecitabine	Other		Drug: capecitabine Other: laboratory biomarker analysis Other: pharmacological study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
capecitabine	Drug		capecitabine
laboratory biomarker analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Capecitabine-related toxicity (i.e., hematological, diarrhea, and hand-foot syndrome) recorded during the first and second courses		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean Marc Ferrero, MD	Centre Antoine Lacassagne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Antoine Lacassagne		Nice		06189	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28481884	Result	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.

ID	Type	Description	Link
CALACASS-DPD-Sein
2008/21
INCA-RECF0942
EUDRACT-2008-004136-20

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines