Clinical Trials /

Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer

NCT02692755

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title:Palbociclib / Letrozole in African American Women With HR+ HER2- Breast Cancer
  • Official Title:Phase II Safety Study of Palbociclib in Combination With Letrozole in African American Women With Hormone Receptor Positive HER2 Negative Advanced Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 2015-1396
  • NCT ID: NCT02692755

Trial Conditions

  • Hormone Receptor Positive HER-2 Negative Breast Cancer

Trial Interventions

DrugSynonymsArms
Palbociclib + LetrozoleSingle ARM

Trial Purpose

This study aims to evaluate the hematological safety of palbociclib with letrozole 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.

Trial Arms

NameTypeDescriptionInterventions
Single ARMOther
  • Palbociclib + Letrozole

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 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

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of patients who complete planned oncologic therapy without the development of a hematological event
Time Frame:12 months
Safety Issue:Yes
Description:For study purpose febrile neutropenia will be defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: "ANC less than 1000/mm3 with a single temperature of >38.3 degrees Celsius (101 degrees Fahrenheit) or a sustained temperature of 38 degrees Celsius (100.4 degrees Fahrenheit) for more than one hour." Planned oncology therapy is defined as completion of one year of therapy for advanced breast cancer in the absence of disease progression or cessation of study drug due to progressive disease or non-hematological toxicity.

Secondary Outcome Measures

Measure:Number of patients who required dose delays in palbociclib attributed to neutropenia.
Time Frame:12 months
Safety Issue:No
Description:
Measure:Number of patients who required dose reductions in palbociclib therapy attributed to neutropenia
Time Frame:12 months
Safety Issue:Yes
Description:
Measure:Clinical Benefit Rate (CBR), for those with evaluable disease, defined as the percentage of patients who achieved complete response, partial response and stable disease
Time Frame:24 weeks
Safety Issue:No
Description:

Trial Keywords

  • African American