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L'essai clinique NCT06806930 pour Cancer du sein stade I, Cancer du sein stade II, Cancer du sein stade III, Carcinome du sein est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
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Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT) Phase II 90

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT06806930 est conçu pour étudier le traitement de Cancer du sein stade I, Cancer du sein stade II, Cancer du sein stade III, Carcinome du sein. Il s'agit d'une étude interventionnel en Phase II. Son statut actuel est : en recrutement. L'étude a débuté le 1 octobre 2024 et vise à recruter 90 participants. Dirigée par l'Université George-Washington, l'étude devrait être terminée d'ici le 1 octobre 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 3 mars 2026.
Résumé succinct

The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called "neoadjuvant" treatment) affects breast cancer. The main questions the trial aims is answer are:

  1. How breast cancer responds to endocrine therapy given prior to surgery?
  2. To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or ...
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Titre officiel

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)

Pathologies
Cancer du sein stade ICancer du sein stade IICancer du sein stade IIICarcinome du sein
Autres identifiants de l'étude
  • Neo-PREDICT
Numéro NCT
NCT06806930
Date de début (réel)
2024-10-01
Dernière mise à jour publiée
2026-03-03
Date de fin (estimée)
2028-10
Inscription (estimée)
90
Type d'étude
Interventionnel
PHASE
Phase II
Statut
En recrutement
Mots clés
breast
cancer
HER2
carcinoma
Objectif principal
Traitement
Méthode d'allocation
Non randomisé
Modèle d'intervention
Parallèle
Masquage
Simple aveugle
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Comparateur actifCohort A: Short Duration NET
Patients in this cohort can be treated with NET up to 8weeks (\<= 8 weeks)
Neoadjuvant endocrine therapy
Cohort A: Short duration NET. Patients in this cohort can be treated with NET up to 8weeks (\<= 8 weeks)
Comparateur actifCohort B: Intermediate Duration NET
Patients in this cohort can be treated with NET \> 8weeks but \<=24 weeks
Neoadjuvant endocrine therapy
Cohort B: Intermediate duration NET. Patients in this cohort can be treated with NET \> 8weeks but \<=24 weeks
Comparateur actifCohort C: Extended Duration NET
Patients in this cohort can be treated with NET \>24 weeks but \<= 52 weeks
Neoadjuvant endocrine therapy
Cohort C: Extended duration NET. Patients in this cohort can be treated with NET \>24 weeks but \<= 52 weeks
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Response to neoadjuvant endocrine therapy (NET)
Response to neoadjuvant endocrine therapy is defined as clear margins (defined as greater than 1mm) measured in the surgical pathology report. The proportion of women in each cohort with response will be estimated with exact 95% binomial confidence intervals. This is a categorical outcome (Success/Failure). Success is defined as clear margins \>1mm; Failure is defined as margins ≤1mm.
From enrollment to the end of treatment at <=52 weeks
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Physicians will predict Preoperative Endocrine Prognostic Index (PEPI) score after NET for subjects enrolled in cohort B or C
Preoperative Endocrine Prognostic Index (PEPI) score is determined from surgical pathology report. The score ranges from 0 to 12. The score is a composite of tumor size, nodal status, Ki67 level, and ER status. Higher scores indicate a worse outcome (increased risk of relapse), while a score of 0 (PEPI-0) represents a superior prognosis.
From enrollment to the end of treatment at <=52 weeks
Physicians will predict Ki67 after NET: Ki67 Labeling Index (percentage of Ki67-positive tumor cells).
Physicians will make a prediction of what the Ki67 will be in the surgical pathology specimen. It will correlate with the surgical pathology report data recorded by pathologist. Ki67 measures the proportion of actively dividing cancer cells. Higher scores indicate a worse outcome (higher cell proliferation and potentially more aggressive disease). Scores range from 0% to 100%.
From enrollment to the end of treatment at <=52 weeks
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
21 Years
Sexes éligibles
Tous
  • Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
  • Be capable of signing and providing written consent in accordance with institutional and federal guidelines
  • Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast
  • Clinical stage 1 to 3 breast cancer
  • Candidate for surgical resection
  • Estrogen receptor > 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.
  • HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.
  • Ability to take oral medication
  • Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
  • Age ≥ 21 years

  • Inability to comply taking NET
  • Inability to comply to study procedures
George Washington University logoUniversité George-Washington
Partie responsable de l'étude
Pavani Chalasani, Investigateur principal, Professor of Medicine; Director, Division of Hematology Oncology, George Washington University
Contact central de l'étude
Contact: Pavani Chalasani, MD, 202-741-2277, [email protected]
1 Centres de l'étude dans 1 pays

District of Columbia

George Washington-Medical Faculty Associates, Washington D.C., District of Columbia, 20037, United States
Richard Lush, PhD, Contact, 202-994-0329, [email protected]
En recrutement