Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer (PALINA)
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| ClinicalTrials.gov Identifier: NCT02692755 |
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Recruitment Status :
Completed
First Posted : February 26, 2016
Results First Posted : August 20, 2021
Last Update Posted : September 28, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hormone Receptor Positive HER-2 Negative Breast Cancer | Drug: Palbociclib + Letrozole or Fulvestrant | Phase 2 Phase 3 |
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.
| 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 |
| 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:
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- 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.
- Dose Delays in Palbociclib Attributed to Neutropenia [ Time Frame: 12 months ]Number of patients who required dose delays in palbociclib attributed to neutropenia.
- Dose Reductions in Palbociclib Therapy Attributed to Neutropenia [ Time Frame: 12 months ]Number of patients who required dose reductions in palbociclib therapy
- 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.
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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:
- 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)
- ER-positive and/or PgR-positive tumor based on local laboratory results
- HER2-negative breast cancer based on local laboratory results (test to be used as per local practice)
- Patients must be appropriate candidates for letrozole or fulvestrant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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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:
- Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4
- Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, as per Investigator's judgment, brain metastases are permitted.
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Previous CDK4/6 inhibitor
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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
| 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 | |
| Principal Investigator: | Claudine Isaacs, MD | MedStar Georgetown University Hospital |
Documents provided by Georgetown University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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African American |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Letrozole Fulvestrant Palbociclib 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 |