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AFT-38

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (PATINA)

Status:

Recruiting | Phase III

Official Title:

A Randomized 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 (PATINA)

Study Purpose:

To determine if adding palbociclib to standard treatment with anti-HER2-based therapy plus endocrine therapy is more effective in preventing cancer from getting worse.

Interventions:

  • Palbociclib (Ibrance)   
  • Lab Biomarker Analysis
  • Quality of Life questionnaires
  • ARM I:  Palbociclib + standard endocrine and anti-HER2-based therapy
  • ARM II: Standard endocrine and anti-HER2-based therapy alone

Patients continue on treatment until cancer worsens. After this, patients are followed every 6 months for 5 years from starting study.

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Stage IV (or Non-Operable) Breast Cancer

Eligibility:

Must be Her2 positive, and ER and/or PR positive.

Patients must be receiving their first line of chemotherapy in the metastatic setting (stage IV). It is okay if patients had chemotherapy before or after surgery for an earlier stage of breast cancer.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

AFT-38

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!