- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02692755
Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer (PALINA)
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
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Lieux d'étude
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District of Columbia
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Washington, District of Columbia, États-Unis, 20007
- MedStar Georgetown University Hospital
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Washington, District of Columbia, États-Unis, 20013
- MedStar Washington Hospital Center
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Illinois
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Chicago, Illinois, États-Unis, 60637
- University of Chicago
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Maryland
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Baltimore, Maryland, États-Unis, 21218
- MedStar Union Memorial Hospital
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Baltimore, Maryland, États-Unis, 21239
- MedStar Good Samaritan Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
- Thomas Jefferson University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
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.
Previous CDK4/6 inhibitor
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Palbociclib + Letrozole or Fulvestrant
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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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Number of Patients Who Complete Planned Oncologic Therapy Without the Development of a Hematological Event
Délai: 12 months
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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. |
12 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Dose Delays in Palbociclib Attributed to Neutropenia
Délai: 12 months
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Number of patients who required dose delays in palbociclib attributed to neutropenia.
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12 months
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Dose Reductions in Palbociclib Therapy Attributed to Neutropenia
Délai: 12 months
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Number of patients who required dose reductions in palbociclib therapy
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12 months
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Clinical Benefit Rate
Délai: 24 weeks
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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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24 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Claudine Isaacs, MD, MedStar Georgetown University Hospital
Publications et liens utiles
Publications générales
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- 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
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- Chen MS Jr, Lara PN, Dang JH, Paterniti DA, Kelly K. Twenty years post-NIH Revitalization Act: enhancing minority participation in clinical trials (EMPaCT): laying the groundwork for improving minority clinical trial accrual: renewing the case for enhancing minority participation in cancer clinical trials. Cancer. 2014 Apr 1;120 Suppl 7(0 7):1091-6. doi: 10.1002/cncr.28575.
- Hsieh MM, Everhart JE, Byrd-Holt DD, Tisdale JF, Rodgers GP. Prevalence of neutropenia in the U.S. population: age, sex, smoking status, and ethnic differences. Ann Intern Med. 2007 Apr 3;146(7):486-92. doi: 10.7326/0003-4819-146-7-200704030-00004.
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies de la peau
- Tumeurs
- Tumeurs par site
- Maladies du sein
- Tumeurs mammaires
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Inhibiteurs de protéine kinase
- Antagonistes hormonaux
- Inhibiteurs de l'aromatase
- Inhibiteurs de la synthèse des stéroïdes
- Antagonistes des œstrogènes
- Antagonistes des récepteurs aux œstrogènes
- Létrozole
- Fulvestrant
- Palbociclib
Autres numéros d'identification d'étude
- 2015-1396
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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Essais cliniques sur Palbociclib + Letrozole or Fulvestrant
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International Cancer Research Group, United Arab...Pfizer; AstraZeneca; Genomic Health®, Inc.ComplétéTumeur mammaire FemmeEmirats Arabes Unis, Algérie, Egypte, Jordan, Liban, Maroc, Arabie Saoudite, Tunisie
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Sun Yat-sen UniversityRecrutement
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Cancer Institute and Hospital, Chinese Academy...RecrutementCancer du sein avancé positif aux récepteurs hormonauxChine
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SOLTI Breast Cancer Research GroupNovartis; Alliance Foundation Trials, LLC.RecrutementCancer du sein métastatiqueÉtats-Unis, Espagne, Le Portugal