Clinical trial NCT02692755: Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer
Official title: Phase II Safety Study of Palbociclib in Combination With Letrozole or Fulvestrant in African American Women With Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer
Keywords: African American
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: Thomas Jefferson University
First posted: 2016-02-26
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer. Hematological safety is a composite endpoint of episodes of febrile neutropenia and treatment discontinuation due to neutropenia according to current recommendations for management of neutropenia

Detailed description: The study is designed to assess the rate of completion of planned oncology therapy in the absence of a hematological event defined as episodes of febrile neutropenia and treatment discontinuation due to neutropenia. A completion rate of 80% is considered of clinical relevance as to benefit breast cancer patients who are at a higher risk of having ethnic neutropenia where as a completion rate of 60% is considered poor and to justify additional safety studies. A two stage design with a total of 35 patients is used to test if the completion rate is at least 80% versus if it is below 60% with 80% power at a significance level of 5%.

An exact confidence interval of the completion rate will be calculated. Investigators estimate there will be no more than a 10% rate of febrile neutropenia. Due to the small sample size, the analysis of secondary endpoints will be descriptive and will not include specific hypothesis testing.

Eligibility criteria: Inclusion Criteria:

1. Self-identified Black, African or African American women of ≥ 18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
2. ER-positive and/or PgR-positive tumor based on local laboratory results
3. HER2-negative breast cancer based on local laboratory results (test to be used as per local practice)
4. Patients must be appropriate candidates for letrozole or fulvestrant therapy
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Adequate bone marrow function:

   * Absolute Neutrophil Count (ANC) ≥ 1,000/mm3 (1.0 x 109/L);
   * Platelets ≥100,000/mm3 (100 x 109/L);
   * Hemoglobin ≥9 g/dL (90 g/L).

Exclusion Criteria:

1. Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4
2. Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, as per Investigator's judgment, brain metastases are permitted.
3. Previous CDK4/6 inhibitor

   -

Primary outcomes:
measure: Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event
timeFrame: 12 months
Secondary outcomes:
measure: Dose Delays in Palbociclib Attributed to Neutropenia
timeFrame: 12 months
measure: Dose Reductions in Palbociclib Therapy Attributed to Neutropenia
timeFrame: 12 months
measure: Clinical Benefit Rate
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: MedStar Good Samaritan Hospital
state: Maryland
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: MedStar Georgetown University Hospital
name: Claudine Isaacs, MD
role: PRINCIPAL_INVESTIGATOR
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