MedTrace Logo

Feasibility Study for the Determination of Oxysterols in Patients With Breast Cancer Receiving Hormonal Therapy With Tamoxifen or Not

NCT01553903 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-04-14

No results posted yet for this study

Summary

This is a biomedical study of interventional type which includes 29 patients on 9 months: 8 months recruiting and 1 month follow up.

Patients with hormone dependent breast cancer metastatic or non-metastatic, for which an indication of hormonal therapy treatment (with tamoxifen or anti-aromatase) is retained, will be enrolled in this study.

The main objective of this study is to evaluate the feasibility for the determination of Oxysterols (CT, CE, OCDO) in this patient population, before and after the initiation of treatment (ie, at D0 before and D28 after beginning of treatment).

Conditions

Interventions

DRUG

Tamoxifen,

Tamoxifen 20 mg/day during 5 years,

DRUG

Exemestane

Exemestane 25mg/day during 5 years

DRUG

Anastrozole

Anastrozole 1 mg/day during 5 years,

DRUG

Letrozole

Letrozole 2.5 mg/day during 5 years,

Sponsors & Collaborators

  • Institut Claudius Regaud

    lead OTHER

Principal Investigators

  • Florence DALENC, MD · Institut Claudius Regaud

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01553903 on ClinicalTrials.gov