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An Observational Study to Assess Response to Tamoxifen in Breast Cancer Patients

NCT00965939 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2015-10-28

No results posted yet for this study

Summary

CYPTAM-BRUT 2 is a prospective, multicentric study including postmenopausal women receiving tamoxifen for metastatic, locally advanced (stage IIIB/C) or in the neoadjuvant setting for measurable estrogen-receptor positive breast cancers. The primary endpoint is the difference in efficacy of tamoxifen, defined as the objective response rate using RECIST criteria, between women with a normal versus low Tamoxifen Activity Score (TAS) after 3-6 months of tamoxifen use. The TAS score is based on the presence of genetic variations and drug interactions. Secondary endpoints are time to progression, clinical benefit, serum metabolite concentrations, endometrial changes and menopausal symptoms. Patients using tamoxifen in the neoadjuvant setting needs being operated between 4-6 months following the start of tamoxifen.

Conditions

  • ER-positive Breast Cancer

Sponsors & Collaborators

  • Vlaamse Vereniging voor Obstetrie en Gynaecologie

    lead OTHER

Principal Investigators

  • Patrick Neven · UZ Leuven

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2014-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00965939 on ClinicalTrials.gov