A Phase 1b/2 Study of Safety and Efficacy of MLN0128 (Dual TORC1/2 Inhibitor) in Combination With Exemestane or Fulvestrant Therapy in Postmenopausal Women With ER+/HER2- Advanced or Metastatic Breast Cancer That Has Progressed on Treatment With Everolimus in Combination With Exemestane or Fulvestrant
Sponsor: |
Millennium Pharmaceuticals, Inc. |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAN6701 |
U.S. Govt. ID: |
NCT02049957 |
Contact: |
Kevin Kalinsky: 2123050170 / kk2693@columbia.edu |
This study involves research; it is the first time that MLN0128 will be studied in patients who are also receiving antihormonal medication. The main purposes of the study are to determine: The risks and discomforts of MLN0128 when given with antihormonal medication. Whether giving MLN0128 in combination with antihormonal medication affects the growthof your tumor(s). How much MLN0128 is in your blood and how your body gets rid of MLN0128 (known aspharmacokinetic or PK measurements). For some patients receiving exemestane asantihormonal medication, the amount of exemestane is in your blood will also be evaluated. How treatment with MLN0128 may affect proteins that are involved in how the study drugworks in the body.
This study is closed
Investigator
Kevin Kalinsky, MD, MS
Have you had any recent anticancer therapy or other investigation therapy within the past few weeks? |
Yes |
No |
Do you have advanced or metastatic breast cancer? |
Yes |
No |