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AFT-38 PATINA

Trial

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

October 31, 2017

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

Principal Investigator Name

Regan Look, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Monday, March 22, 2021 02:43:46 PM