Predicting Response to Capecitabine in Women With Metastatic Breast Cancer

NCT00953537 | Completed

• 5 other identifiers: CDR0000638377CALACASS-DPD-Sein2008/21INCA-RECF0942EUDRACT-2008-004136-20
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Capecitabine-related toxicity (i.e., hematological, diarrhea, and hand-foot syndrome) recorded during the first and second courses

  3 months

Study Arms (1)

capecitabine

OTHER

Drug: capecitabine; Other: laboratory biomarker analysis; Other: pharmacological study

Interventions

capecitabine DRUG

capecitabine

laboratory biomarker analysis OTHER

capecitabine

pharmacological study OTHER

capecitabine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Related Publications (1)

• 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.

  PMID: 28481884 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jean Marc Ferrero, MD

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 6, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

FR (1)