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

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Completed

CT.gov ID

NCT01553903

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Tamoxifen, Drug: Exemestane Drug: Anastrozole Drug: Letrozole	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2011

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

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,

Outcome Measures

Primary Outcome Measures

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

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]
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)
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]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.