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

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ClinicalTrials.gov Identifier: NCT02692755
Recruitment Status : Completed
First Posted : February 26, 2016
Results First Posted : August 20, 2021
Last Update Posted : September 28, 2021
University of Chicago
Thomas Jefferson University
Information provided by (Responsible Party):
Georgetown University

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

Condition or disease Intervention/treatment Phase
Hormone Receptor Positive HER-2 Negative Breast Cancer Drug: Palbociclib + Letrozole or Fulvestrant Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 16, 2019
Actual Study Completion Date : March 23, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Palbociclib + Letrozole or Fulvestrant Drug: Palbociclib + Letrozole or Fulvestrant
Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
Other Names:
  • Ibrance
  • Femara
  • Faslodex

Primary Outcome Measures :
  1. Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event [ Time Frame: 12 months ]

    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 :
  1. Dose Delays in Palbociclib Attributed to Neutropenia [ Time Frame: 12 months ]
    Number of patients who required dose delays in palbociclib attributed to neutropenia.

  2. Dose Reductions in Palbociclib Therapy Attributed to Neutropenia [ Time Frame: 12 months ]
    Number of patients who required dose reductions in palbociclib therapy

  3. Clinical Benefit Rate [ Time Frame: 24 weeks ]
    Clinical Benefit Rate (CBR), for those with evaluable disease, defined as the percentage of patients who achieved complete response, partial response and stable disease. RECIST 1.1 was used as the standard way to measure response to treatment. The mean (SD) of specific metabolites were calculated at each time point and graphically assess these measures over time with clinical response and hematological toxicity. The mean change in these variables from baseline to each follow-up point was be calculated. Generalized linear model was utilized for the correlative analysis of clinical response and hematologic events.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02692755

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United States, District of Columbia
MedStar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20013
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
MedStar Union Memorial Hospital
Baltimore, Maryland, United States, 21218
MedStar Good Samaritan Hospital
Baltimore, Maryland, United States, 21239
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Georgetown University
University of Chicago
Thomas Jefferson University
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Principal Investigator: Claudine Isaacs, MD MedStar Georgetown University Hospital
  Study Documents (Full-Text)

Documents provided by Georgetown University:
Wood WC, Muss HB, Solin LJ, Olopade OI. Malignant Tumors of the Breast. In: DeVita VT Jr, Hellmann S, Rosenberg SA, editors. Cancer, Principle and Practice of Oncology, 7thEdition, Lippincott Williams and Wilkins; 2005; 1415-1477.
A study of Palbociclib (PD-0332991) + letrozole vs. letrozole for first line treatment of postmenopausal women with ER/HER2- advanced breast cancer (PALOMA-2). Available at: https://clinicaltrials.gov/ct2/show/NCT01740427. Accessed on August 9, 2015
NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT02692755    
Other Study ID Numbers: 2015-1396
First Posted: February 26, 2016    Key Record Dates
Results First Posted: August 20, 2021
Last Update Posted: September 28, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Georgetown University:
African American
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Protein Kinase Inhibitors