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From the Characterization of the Cholesterol-epoxide Pathway Deregulation to New Therapeutic Perspectives in Breast Cancers (BREASTEROL)

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ClinicalTrials.gov Identifier: NCT02863900
Recruitment Status : Not yet recruiting
First Posted : August 11, 2016
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
Institut Claudius Regaud

Brief Summary:
The main objective of our project is to further characterize the deregulation of CE (Cholesterol Epoxides) metabolism in different moleculars subtypes of BC (BC=Breast Cancer) (luminal A and B, HER2+ and triple negative). We will study not only the level of expression of the enzymes involved in this pathway by immuno-histochemistry, all the enzymes involved were identified in our preclinical work (GSTA1 (Glutathione S-Transferase A1 ), DHCR7, D8D7I, 11βHSD2 (11β-hydroxysteroid dehydrogenase of type 2 )), but also the metabolite rates of CE (hydrolyses cholesterols-5,6-epoxide ), CT (into cholestane-3β, 5α, 6β triol ), DDA (Dendrogenin A)and OCDO (6-oxo-cholestan-3β, 5α-diol ). Our preliminary results demonstrate the feasibility of these dosages. We will also establish whether these deregulations are i) correlated with different histo-prognostic parameters (pN (N= Node), pT (T= Tumor) , EV, TIL…) but also clinical ii) an independent prognostic parameter of BC in terms of disease-free survival, metastasis-free survival and overall survival. The cohort consists of 350 cases of BC, treated between 2009 and 2011 as well as all relevant clinical informations. In parallel, we will continue our preclinical work by characterizing the targets and mechanisms of action of OCDO. Our preliminary results indicate that OCDO is a modulator of the glucocorticoid receptor (GR), which could be target to inhibit this pathway. On the other hand, we will characterize in the same manner as in human tumors, the deregulations of the CE metabolism in vitro and in vivo (including xenografts in mice of human tumors, in collaboration with Roman-Roman S) on a representative panel of BC molecular subtypes, sensitive or not usually administered in clinical treatment and study the anti-tumor effect of various "anti-OCDO" therapies (therapies preventing its production such as Tam (tamoxifen) or DDA, inhibitor of the enzyme producing OCDO, or an inhibitor of the GR (glucocorticoid receptor )), alone or in combination with conventional therapies

Condition or disease Intervention/treatment Phase
Breast Cancer Other: cohort of BC of each subtypes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: From the Characterization of the Cholesterol-epoxide Pathway Deregulation to New Therapeutic Perspectives in Breast Cancers
Study Start Date : December 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental arm
subtypes of BC (namely luminal A and luminal B, HER2+, TN)
Other: cohort of BC of each subtypes



Primary Outcome Measures :
  1. Occurrence of the deregulations of CE metabolism in the different molecular subtypes of BC (namely luminal A and luminal B, HER2+, TN) [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Compare CE metabolism characterisation and immune infiltrate by quantification of TILs (infiltrating-lymphocytes) [ Time Frame: up to 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years old
  • Affiliated to the French social security system.
  • Subjects must provide written informed consent prior to any study-specific procedure or assessment

Exclusion Criteria:

  • Pregnant or breastfeeding woman
  • Subject law protected
  • Any serious and/or unstable pre-existing psychiatric,familial, geographic or social condition that could interfere with medical follow-up and compliance to study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863900


Contacts
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Contact: Marc POIROT 0033 5 81 74 16 26 marc.poirot@inserm.fr
Contact: Florence DALENC, MD 0033 5 31 15 51 04 dalenc.florence@iuct-oncopole.fr

Locations
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France
Institut Claudius Regaud Not yet recruiting
Toulouse, France, 31059
Contact: FLORENCE DALENC, MD    0033 5 31 15 51 04    dalenc.florence@iuct-oncopole.fr   
Sponsors and Collaborators
Institut Claudius Regaud
Investigators
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Principal Investigator: Florence DALENC, MD Institut Claudius Regaud

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Responsible Party: Institut Claudius Regaud
ClinicalTrials.gov Identifier: NCT02863900     History of Changes
Other Study ID Numbers: 16SEIN04
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases