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Completed

NCT Number: NCT01553903

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

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Institut Claudius REGAUD

Toulouse, 31052, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient with breast cancer HER2 positive (IHC and / or FISH-CISH)
  • Patient already receiving hormonal therapy or patient who has not stopped hormonal therapy for at least 21 days.
  • Patient that should receive a chemotherapy and / or another targeted therapy (other than hormonal therapy) for the treatment of the breast cancer.
  • 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.
  • Patient unable to follow procedures, visits, examinations described in the study.
  • Pregnant women or nursing mothers can not participate in the study.
  • Patients under legal guardianship.

Treatment and study plan

Tamoxifen,

Drug

Tamoxifen 20 mg/day during 5 years,

Exemestane

Drug

Exemestane 25mg/day during 5 years

Anastrozole

Drug

Anastrozole 1 mg/day during 5 years,

letrozole

Drug

Letrozole 2.5 mg/day during 5 years,

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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).

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: OXYTAM

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 14, 2012
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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