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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT01553903
First received: December 20, 2011
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Tamoxifen,
Drug: Exemestane
Drug: Anastrozole
Drug: Letrozole
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Institut Claudius Regaud:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: 2 time points (D0 and D28) over a period of 2 years ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2 time points (D0 and D28) over a period of 2 years ] [ Designated as safety issue: No ]
    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).


Enrollment: 29
Study Start Date: December 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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,

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01553903

Locations
France
Institut Claudius REGAUD
Toulouse, France, 31052
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
Principal Investigator: Florence DALENC, MD Institut Claudius Regaud
  More Information

No publications provided

Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT01553903     History of Changes
Other Study ID Numbers: 11 SEIN 09
Study First Received: December 20, 2011
Last Updated: June 3, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Claudius Regaud:
Hormonal therapy
Breast Cancer
AEBS
Oxysterols

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Anastrozole
Exemestane
Letrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014