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

Breast Cancer Clinical Trial

— OXYTAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553903
• Other study ID #: 11 SEIN 09
• Status: Completed
• Phase: Phase 4
• First received: December 20, 2011
• Last updated: June 3, 2013
• Start date: December 2011
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tamoxifen,
Tamoxifen 20 mg/day during 5 years,
• Exemestane
Exemestane 25mg/day during 5 years
• Anastrozole
Anastrozole 1 mg/day during 5 years,
• Letrozole
Letrozole 2.5 mg/day during 5 years,

Locations

Country	Name	City	State
France	Institut Claudius REGAUD	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with Tamoxifen	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	No
Secondary	Measure of Oxysterols (OCDO, CT and CE) plasma concentrations in patient treated with anti-aromatase.	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	No