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Brief Title: S 81694 Plus Paclitaxel in Metastatic Breast Cancer
Official Title: Phase I/II Trial of S 81694 Administered Intravenously in Combination With Paclitaxel to Evaluate the Safety, Pharmacokinetic and Efficacy in Metastatic Breast Cancer
Study ID: NCT03411161
Brief Summary: The purpose of this study is to determine the safety profile, the maximum tolerated dose (MTD) and the associated dose-limiting toxicities (DLTs) of S 81694 in combination with paclitaxel in metastatic breast cancer (mBC) patients, and to investigate the antitumour activity of the combination in metastatic triple negative breast cancer (mTNBC) patients.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institut Jules Bordet Clinique Oncologie Médicale, Bruxelles, , Belgium
UZ Leuven Campus Gasthuisberg Dept. of General Medical, Leuven, , Belgium
Institut de Cancérologie de l'Ouest site Saint Herblain, Saint Herblain, , France
Chiba cancer center Breast surgery, Chiba, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Erasmus MC Section Clinical Pharmacology, Rotterdam, , Netherlands
Name: Mario CAMPONE, Pr
Affiliation: Institut de Cancérologie de l'Ouest site Saint Herblain
Role: PRINCIPAL_INVESTIGATOR