AFT-38 PATINA

Clinical Trial Title Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA)
Trial Status Closed to Enrollment
Start Date 10/31/2017
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Breast Cancer
Description The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.
Eligibility Criteria
  • Participants must have histologically confirmed invasive breast cancer that is metastatic or not amenable for resection or radiation therapy with curative intent. Histological documentation of metastatic/recurrent breast cancer is not required if there is unequivocal evidence for recurrence of the breast cancer
  • Age ≥18 years (or per national guidelines)
  • ECOG performance status 0-1
  • Patients must have histologically confirmed HER2+ and hormone receptor positive (ER+ and/or PR+), metastatic breast cancer
  • Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption
     

Exclusion Criteria

  • Concurrent therapy with other Investigational Products
  • Prior therapy with any CDK inhibitor

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes https://clinicaltrials.gov/ct2/show/NCT02947685
Principal Investigator Regan Look, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org