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

April 9, 2026 updated by: Institut Claudius Regaud

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31052
        • Institut Claudius Regaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women of more than 18 years old (menopause or not).
  2. Women with invasive breast cancer metastatic or non-metastatic, for which treatment with tamoxifen or anti-aromatase is retained.
  3. Cancer hormone-expressing estrogen receptor (ER) and / or progesterone receptor (PR) (≥ 10% of tumor cells in Technical HIC).
  4. Any previous hormonal therapy, stopped for progression, should be discontinued for at least 21 days prior to study entry.
  5. WHO ≤ 2.
  6. Women of childbearing age must use effective contraception for the duration of the study.
  7. Informed consent obtained and signed before any specific procedure in the study.
  8. Patient member in a national insurance scheme.

Exclusion Criteria:

  1. Patient with breast cancer HER2 positive (IHC and / or FISH-CISH)
  2. Patient already receiving hormonal therapy or patient who has not stopped hormonal therapy for at least 21 days.
  3. Patient that should receive a chemotherapy and / or another targeted therapy (other than hormonal therapy) for the treatment of the breast cancer.
  4. Any other medical or psychiatric condition or laboratory abnormality severe, acute or chronic making the inclusion of the patient in the study inappropriate in the opinion of the investigator.
  5. Patient unable to follow procedures, visits, examinations described in the study.
  6. Pregnant women or nursing mothers can not participate in the study.
  7. Patients under legal guardianship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tamoxifen,
Current hormonotherapy treatment in hormone dependent breast cancer
Drug: Tamoxifen,
Tamoxifen 20 mg/day during 5 years,
Experimental: Exemestane
Current hormonotherapy treatment in hormone dependent breast cancer
Drug: Exemestane
Exemestane 25mg/day during 5 years
Experimental: Anastrozole
Current hormonotherapy treatment in hormone dependent breast cancer
Drug: Anastrozole
Anastrozole 1 mg/day during 5 years,
Experimental: Letrozole
Current hormonotherapy treatment in hormone dependent breast cancer
Drug: Letrozole
Letrozole 2.5 mg/day during 5 years,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of Oxysterols (OCDO, CT and CE)plasma concentrations by Gaz Chromatography coupled to mass spectrometry (GC/MS)in human.
Time Frame: 2 time points (D0 and D28) over a period of 2 years

Oxysterols measured are the following : OCDO (6-oxo-cholestan-3 beta, 5 alpha-diol), CE (cholesterol-5,6-eposides) and CT (cholestane-3 beta, 5 alpha, 6 beta-triol).

Calibration curve will be established for each Oxysterol by GC/MS using deuterated analogues of each oxysterols for the quantification.
2 time points (D0 and D28) over a period of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with Tamoxifen
Time Frame: 2 time points (D0 and D28) over a period of 2 years
Plasma concentrations of Oxysterols evaluated by Gaz chromatography coupled to mass spectrometry (GC/MS)in patients after 28 days of hormonal therapy with Tamoxifen in order to determine the impact of the treatment on these plasmatic concentrations(D28 oxysterols plasma concentrations will be compared to D0 oxysterols plasma concentrations)
2 time points (D0 and D28) over a period of 2 years
Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with anti-aromatase.
Time Frame: 2 time points (D0 and D28) over a period of 2 years
Plasma concentrations of Oxysterols evaluated by Gaz chromatography coupled to mass spectrometry (GC/MS)in patients after 28 days of hormonal therapy with anti-aromatase (Anastrozole, Letrozole or Exemestane) in order to determine the absence of impact of the treatment on these plasmatic concentrations (D28 oxysterols plasma concentrations will be compared to D0 oxysterols plasma concentrations).
2 time points (D0 and D28) over a period of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Investigators

  • Principal Investigator: Florence DALENC, MD, Institut Claudius Regaud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

March 12, 2012

First Posted (Estimated)

March 14, 2012

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11 SEIN 09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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