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Alliance A171601

Status:

Recruiting | Phase II

Official Title:

A Phase II Trial Assessing the Tolerability Of Palbociclib In Combination With Letrozole Or Fulvestrant In Patients Aged 70 And Older With Estrogen Receptor Positive, Her2-Negative Metastatic Breast Cancer

Study Purpose:

To find out the side effects that the standard, FDA-approved combination treatment of letrozole or fulvestrant and palbociclib has on patients 70 years old and over.

Interventions:

  • Palbociclib (Ibrance)
  • Fulvestrant (Faslodex) or Letrozole (Femara)
  • Quality of Life Questionnaires
  • Lab Biomarker Analysis
  • SINGLE ARM: Palbociclib 125mg PO daily + Letrozole or Fulvestrant

Patients will be followed every year for up to 5 years following end of treatment. End of treatment occurs when patient experiences progression of disease or unacceptable side effect.

Key Participation Requirements: 

Gender: 

Male or female

Age:

70 years and older

Diagnosis:

Metastatic Breast Cancer

Marker Status:

All ER positive, Her2 negative

Prior Therapy:

MD planning to begin patient on endocrine therapy. One prior line of endocrine therapy allowed.

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

Methodist Health System Trial Code:

Alliance A171601

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!