Study on Fulvestrant and Palbociclib or Aromatase Inhibitor Therapy for Older Patients with Hormone Responsive Breast Cancer That Cannot Be Removed by Surgery

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02760030

Provider View

This clinical trial is exploring how well the combination of fulvestrant and palbociclib works in treating older patients with hormone-responsive breast cancer that cannot be surgically removed. The study aims to see if this combination can effectively control the cancer by blocking estrogen and stopping cancer cell growth.

Patient Parameters

Program Overview

This phase II study is testing a treatment for older patients with breast cancer that responds to hormones but cannot be removed by surgery. The treatment uses two drugs: fulvestrant, which blocks estrogen from helping cancer grow, and palbociclib, which stops cancer cells from growing by blocking certain enzymes. The goal is to see if using these drugs together can effectively treat hormone-responsive breast cancer.

Description

The main goal of this study is to find out how long patients can go without their cancer getting worse when treated with fulvestrant and palbociclib. This is called treatment failure-free survival (TFFS). The study focuses on patients aged 70 and older who have newly diagnosed, non-metastatic breast cancer that is hormone receptor-positive and HER-2 negative.

Secondary goals include:

  • Checking how long patients can live without the cancer progressing over one and two years.
  • Evaluating the safety and side effects of the treatment in patients aged 70 and older.
  • Seeing if changes in health assessments for older adults relate to how well patients tolerate the treatment.

In this study, patients receive fulvestrant through an injection on days 1 and 15. They also take palbociclib by mouth once a day from days 1 to 21. This cycle repeats every 28 days as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients are monitored for 12 weeks.

Eligibility Criteria

Inclusion Criteria

  • Have newly diagnosed invasive breast cancer that is estrogen receptor (ER) and/or progesterone receptor (PR)-positive and HER2 negative, with more than 10% staining in tests.
  • Be considered vulnerable or frail according to specific criteria, or refuse breast surgery. Vulnerable patients may have some dependence in daily activities and controlled health issues, while frail patients may have multiple health issues and significant dependence.
  • Have documented refusal of breast surgery by both the surgeon and medical oncologist.
  • Have adequate blood counts and organ function, including:
    • Neutrophil count over 1000/uL
    • Platelet count over 75,000/L
    • Serum creatinine within 1.5 times the normal limit
    • Total bilirubin less than 1.5 times the normal limit
    • Liver enzymes (AST/ALT) within 2.5 times the normal limit
  • Be able to understand and willing to sign a consent form.

Exclusion Criteria

  • Have previously received aromatase inhibitor therapy.
  • Have evidence of cancer spread to distant parts of the body.
  • Have a psychiatric condition that prevents understanding or consenting to the study.
  • Be taking medications that strongly affect the enzyme CYP3A4.

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