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

Phase 4
18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Florence DALENC, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

11 SEIN 09



Start Date:

December 2011

Completion Date:

May 2013

Related Keywords:

  • Breast Cancer
  • Hormonal therapy
  • Breast Cancer
  • AEBS
  • Oxysterols
  • Breast Neoplasms