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

NCT01553903 | Completed Phase 4

• 1 other identifier: 11 SEIN 09
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

Hormonal therapy; Breast Cancer; AEBS; Oxysterols

Outcome Measures

Primary Outcomes (1)

• Determination of Oxysterols (OCDO, CT and CE)plasma concentrations by Gaz Chromatography coupled to mass spectrometry (GC/MS)in human.

  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 Outcomes (2)

• Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with Tamoxifen

  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.

  2 time points (D0 and D28) over a period of 2 years

Study Arms (4)

Tamoxifen,

EXPERIMENTAL

Current hormonotherapy treatment in hormone dependent breast cancer

Drug: Tamoxifen,

Exemestane

EXPERIMENTAL

Current hormonotherapy treatment in hormone dependent breast cancer

Drug: Exemestane

Anastrozole

EXPERIMENTAL

Current hormonotherapy treatment in hormone dependent breast cancer

Drug: Anastrozole

Letrozole

EXPERIMENTAL

Current hormonotherapy treatment in hormone dependent breast cancer

Drug: Letrozole

Interventions

Tamoxifen, DRUG

Tamoxifen 20 mg/day during 5 years,

Tamoxifen,

Exemestane DRUG

Exemestane 25mg/day during 5 years

Exemestane

Anastrozole DRUG

Anastrozole 1 mg/day during 5 years,

Anastrozole

Letrozole DRUG

Letrozole 2.5 mg/day during 5 years,

Letrozole

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut Claudius REGAUD

Toulouse, 31052, France

Location

Related Publications (1)

• Dalenc F, Iuliano L, Filleron T, Zerbinati C, Voisin M, Arellano C, Chatelut E, Marquet P, Samadi M, Roche H, Poirot M, Silvente-Poirot S. Circulating oxysterol metabolites as potential new surrogate markers in patients with hormone receptor-positive breast cancer: Results of the OXYTAM study. J Steroid Biochem Mol Biol. 2017 May;169:210-218. doi: 10.1016/j.jsbmb.2016.06.010. Epub 2016 Jun 22.

  PMID: 27343991 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; exemestane; Anastrozole; Letrozole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Florence DALENC, MD

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: March 14, 2012
• Study Start: December 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (1)