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AFT-38 PATINA

Trial

Clinical Trial Title

AFT-38 PATINA

Trial Status

Open to Enrollment

Start Date

October 31, 2017

Location

Trial Type

Cancer (Oncology)

Specific Condition

Breast Cancer

Description

A Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 therapy + Endocrine Therapy vs. Anti-HER2 therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive 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: Friday, December 29, 2017 09:24:11 AM