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Spots Global Cancer Trial Database for A Multicenter Trial Assessing the Efficacy and Safety of tamOxifen Plus LY2228820 in Advanced or Metastatic Breast Cancer Progressing on aromatasE Inhibitors

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Trial Identification

Brief Title: A Multicenter Trial Assessing the Efficacy and Safety of tamOxifen Plus LY2228820 in Advanced or Metastatic Breast Cancer Progressing on aromatasE Inhibitors

Official Title: A Randomized Open-label Phase II Multicenter Trial Assessing the Efficacy and Safety of tamOxifen Plus LY2228820 in Advanced or Metastatic Breast Cancer Progressing on aromatasE Inhibitors

Study ID: NCT02322853

Study Description

Brief Summary: Metastatic breast cancer (MBC) remains an incurable disease and despite an improvement of the effect of systemic treatments. After relapse on first-line non-steroidal aromatase inhibitor, current clinical practice and treatment guidelines include tamoxifen, fulvestrant (an ER antagonist) and exemestane as available options (NCCN treatment guidelines 2012), but in this context of resistance, their efficacy are poor. Some results confirm the possibility to improve the efficacy of tamoxifen in metastatic setting by a combination with therapy targeting signal transduction pathways. Other transduction pathways seem to be involved in endocrine sensitivity/resistance, such as RAS/RAF/MEK/MAK pathway. LY2228820 inhibits the activity of p38 MAPK (selective inhibitor of the α and β isoforms of p38 MAPK in vitro) and reduces phosphorylation of its cellular target, MAPK-activated protein kinase 2 (MAPKAP-K2).

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Institut Bergonié, Bordeaux, , France

Centre François Baclesse, Caen, , France

Centre Jean Perrin, Clermont -Ferrand, , France

Centre Georges-François Leclerc, Dijon, , France

Centre Léon Bérard, Lyon, , France

Institut Paoli Calmettes, Marseille, , France

Institut de Cancérologie de l'Ouest, Nantes, , France

Hegp, Ap-Hp, Paris, , France

Hôpital St Louis, AP-HP, Paris, , France

Centre Eugène Marquis, Rennes, , France

Centre Henri Becquerel, Rouen, , France

Institut Curie, St Cloud, , France

Institut Claudius Regaud, Toulouse, , France

Institut Gustave Roussy, Villejuif, , France

Contact Details

Name: Christelle LEVY, MD

Affiliation: c.levy@baclesse.unicancer.fr

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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