Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor

Arms (2)

1. type

   ACTIVE_COMPARATOR

   label

   Arm 1 (Dasatinib +Fulvestrant)

   interventionNames

   1. Drug: Dasatinib
   2. Drug: Fulvestrant

2. type

   ACTIVE_COMPARATOR

   label

   Arm 2 (Fulvestrant)

   interventionNames

   1. Drug: Fulvestrant

Primary outcomes (1)

1. measure

   Number of Participants With Disease Progression (PD) or Death

   timeFrame

   Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)

   description

   This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up.