Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer

Arms (2)

1. type

   EXPERIMENTAL

   label

   MM-121 (SAR256212) + exemestane

   interventionNames

   1. Drug: MM-121
   2. Drug: Exemestane

2. type

   PLACEBO_COMPARATOR

   label

   Placebo + exemestane

   interventionNames

   1. Drug: Placebo
   2. Drug: Exemestane

Primary outcomes (1)

1. measure

   Progression Free Survival (PFS)

   timeFrame

   Time from first dose to date of progression, the longest time frame of 79.1 weeks

   description

   To determine whether MM-121 + exemestane was more effective than placebo + exemestane in prolonging progression-free survival. PFS was a time to event measure, and progression of disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), "as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions". Progression free survival was defined as the number of months from the date of randomization to the date of death or progression. If neither death nor progression was observed during the study, PFS data was censored at the last non-progressive disease valid tumor assessment unless the patient was discontinued due to symptomatic deterioration. If this occurred, the patient was counted as having progressive disease (PD).