Essais cliniques sur Cancer du sein métastatique - Registre des essais cliniques

Aperçu de l'étude

Statut

Complété

Les conditions

Cancer du sein métastatique

Description détaillée

Les patients atteints de CS HR+/HER2- métastatique/localement avancé dont la décision de traitement par palbociclib a été prise par leur médecin traitant et qui répondent aux critères d'éligibilité seront invités à participer à l'étude. Les patients qui initient un traitement par palbociclib plus létrozole/inhibiteur de l'aromatase ou palbociclib plus fulvestrant conformément à la ou aux indications autorisées, en tant que traitement de première ou de deuxième ligne pour le cancer du sein métastatique/localement avancé lors de l'inscription peuvent être inclus dans l'étude.

Les variables évaluées dans cette étude seront les données démographiques des patients, les caractéristiques cliniques, les affections comorbides et les médicaments concomitants, les antécédents de traitement du CS HR+ HER2 localement avancé et métastatique, le traitement actuel du CS, l'état de performance (Eastern Cooperative Oncology Group (ECOG), les résultats cliniques et Qualité de vie. Toutes les évaluations décrites dans ce protocole sont effectuées dans le cadre de la pratique clinique normale ou des directives de pratique standard pour la population de patients et la spécialité des prestataires de soins de santé dans les pays où cette étude non interventionnelle est menée. Toutes les données recueillies dans cette étude sont destinées à saisir les schémas de traitement et les résultats du monde réel pour les patients atteints de CS HR+/HER2- métastatique/localement avancé. Un formulaire électronique de rapport de cas (eCRF) sera utilisé pour la collecte des données. Les enquêteurs seront formés avec une première visite sur place à la clinique sur le protocole, le système de saisie électronique des données (EDC) (c'est-à-dire eCRF), le fichier maître du site de l'investigateur (ISMF), la documentation et tout processus d'étude applicable. Toute nouvelle information pertinente pour la réalisation de cette étude non interventionnelle (ENI) sera transmise au personnel médical au cours de l'étude. Une surveillance à distance des données sera effectuée pendant la durée de l'étude pour assurer la communication en temps opportun des données de sécurité, l'intégrité et la cohérence des données.

Type d'étude

Observationnel

Inscription (Réel)

185

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Arabie Saoudite
- - Dammam, Arabie Saoudite
    - King Fahad Specialist Hospital KFSH-Dammam
  - Riyadh, Arabie Saoudite
    - National Guard Hospital, Riyadh
Egypte
- - Alexandria, Egypte
    - Alexandria School of Medicine/Clinical Research Center CRC
  - Cairo, Egypte, 11796
    - National Cancer Institute
  - Cairo, Egypte
    - Ain Shams University Hospital
  - Cairo, Egypte, 11745
    - Dar El Salam Oncology Hospital
Jordan
- - Amman, Jordan, 11941
    - King Hussein Cancer Center
Liban
- - Beirut, Liban
    - American University of Beirut Medical Center
  - Beirut, Liban
    - Hôtel Dieu de France (HDF)
  - Jdeidé - Metn, Liban
    - Saint Joseph Hospital - Cancer Centers of Colorado
  - Sidon, Liban
    - Hammoud Hospital University Medical Center (HHUMC)
Qatar
- - Doha, Qatar
    - Hamad Medical Corporation

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 90 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patientes atteintes d'un cancer du sein HR+/HER2- métastatique/localement avancé

La description

Critère d'intégration:

≥ 18 ans ou plus avec un diagnostic d'adénocarcinome du sein avec des signes de maladie métastatique/localement avancée ne pouvant pas être traitée à visée curative.
Tumeur HR+ (ER+ et/ou PR+) documentée selon les normes locales
Tumeur HER2 documentée selon les normes locales
Initiera un traitement par palbociclib plus létrozole/inhibiteur de l'aromatase ou palbociclib plus fulvestrant conformément à la ou aux indications autorisées, en tant que traitement de première ou de deuxième ligne pour le cancer du sein métastatique/localement avancé lors de l'inscription
Patients qui, de l'avis de l'investigateur, sont disposés et capables de se conformer aux visites régulières à la clinique
Preuve d'un document de consentement éclairé personnellement signé et daté indiquant que le patient (ou un représentant légalement acceptable) a été informé de tous les aspects pertinents de l'étude

Critère d'exclusion:

Patients participant à tout essai clinique interventionnel
Patients sous traitement actif pour des tumeurs malignes autres que le CB métastatique/localement avancé au moment de l'inscription
Patients incapables de comprendre la nature de l'étude et qui ne veulent pas signer un consentement éclairé

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Modèles d'observation: Cohorte
Perspectives temporelles: Éventuel

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Percentage of Participants Who Were Progression Free at 6 Months Post Palbociclib Initiation Délai: At 6 months from the date of palbociclib initiation in routine clinical practice	Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the electronic case report form (e-CRF). Kaplan-Meier method was used.	At 6 months from the date of palbociclib initiation in routine clinical practice
Percentage of Participants Who Were Progression Free at 12 Months Post Palbociclib Initiation Délai: At 12 months from the date of palbociclib initiation in routine clinical practice	Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used.	At 12 months from the date of palbociclib initiation in routine clinical practice
Percentage of Participants Who Were Progression Free at 18 Months Post Palbociclib Initiation Délai: At 18 months from the date of palbociclib initiation in routine clinical practice	Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used.	At 18 months from the date of palbociclib initiation in routine clinical practice
Percentage of Participants Who Were Progression Free at 24 Months Post Palbociclib Initiation Délai: At 24 months from the date of palbociclib initiation in routine clinical practice	Percentage of participants who were progression free was defined as percentage of participants who were alive and for whom no progression of disease was reported. Progression of disease was defined as an increase in visible disease and/or presence of any new lesions, which were evaluated as per local guidelines by the clinician and were collected in the e-CRF. Kaplan-Meier method was used.	At 24 months from the date of palbociclib initiation in routine clinical practice
Percentage of Participants Who Were Alive at 1 Year Post Palbociclib Initiation Délai: At 1 year from the date of palbociclib initiation in routine clinical practice	Percentage of participants who were alive at 1 year post palbociclib initiation were reported in this outcome measure.	At 1 year from the date of palbociclib initiation in routine clinical practice
Percentage of Participants Who Were Alive at 2 Years Post Palbociclib Initiation Délai: At 2 year from the date of palbociclib initiation in routine clinical practice	Percentage of participants who were alive at 2 years post palbociclib initiation were reported in this outcome measure.	At 2 year from the date of palbociclib initiation in routine clinical practice

Mesures de résultats secondaires

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Pfizer

Les enquêteurs

Directeur d'études: Pfizer CT.gov Call Center, Pfizer

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

To obtain contact information for a study center near you, click here.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 juillet 2021

Achèvement primaire (Réel)

29 avril 2025

Achèvement de l'étude (Réel)

29 avril 2025

Dates d'inscription aux études

Première soumission

8 juin 2021

Première soumission répondant aux critères de contrôle qualité

23 juin 2021

Première publication (Réel)

24 juin 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

A5481150
PRECIOUS (Autre identifiant: Alias Study Number)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Pfizer fournira un accès aux données individuelles des participants anonymisés et aux documents d'étude connexes (par ex. protocole, plan d'analyse statistique (PAS), rapport d'étude clinique (CSR)) à la demande de chercheurs qualifiés, et sous réserve de certains critères, conditions et exceptions. De plus amples détails sur les critères de partage des données de Pfizer et le processus de demande d'accès sont disponibles sur : https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Mesure des résultats	Description de la mesure	Délai
Objective Response Rate (ORR) Délai: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	ORR was defined as the percentage of participants with an overall tumor response of complete response (CR) or partial response (PR) or stable disease. Complete response was defined as complete reduction of all visible disease; partial response was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease; stable disease was defined as no change in overall size of visible disease, also including cases where some lesions increased in size and some lesions decreased in size. The responses were evaluated as per local guidelines by the clinician and were collected in the e-CRF.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Time From Initial Breast Cancer Diagnosis to Recurrence of Breast Cancer Délai: At baseline (prior to initiation of palbociclib treatment)	Data for time from initial breast cancer diagnosis to recurrence of breast cancer was collected at baseline from participants medical records.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Stage of Breast Cancer Délai: At baseline (prior to initiation of palbociclib treatment)	Breast cancer stages included Stage I,IIA,IIB,IIIA,IIIB,IIIC as determined using Tumor Node Metastasis (TNM) classification system. Stage I: cancer is small and only in breast tissue or may be found in lymph nodes close to breast. Stage 2: there is cancer in breast or nearby lymph nodes or both. Stage IIA: no tumor found in breast, but cancer is found in one to three axillary lymph nodes, tumor measures 2 centimeter (cm) or smaller; IIB: tumor is larger than 2 cm. Stage 3: cancer is found in lymph nodes close to breast, skin of breast, or chest wall. Stage IIIA: any size tumor; spread to four to nine lymph nodes. Stage IIIB: any size tumor and has spread to chest wall and/or skin of breast and may have spread to up to nine axilliary lymph nodes or near breastbone. Stage IIIC: any size tumor and may have spread to chest wall or skin of breast and ten or more lymph nodes. Higher stage indicates more advanced disease.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Node Status Délai: At baseline (prior to initiation of palbociclib treatment)	Number of participants classified according to node status were reported in this outcome measure. Node status included: N0, N1, N2, N3, NX. N0: there is no cancer in nearby lymph nodes, N1, N2 and N3: number and location of lymph nodes that contained cancer and NX: cancer is nearby lymph nodes cannot be measured.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Menopausal Status Délai: At baseline (prior to initiation of palbociclib treatment)	Number of participants classified according to menopausal status were reported in this outcome measure. Menopausal status included: pre-menopausal and post-menopausal.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Prescribed Palbociclib Combination Délai: At baseline (prior to initiation of palbociclib treatment)	Number of participants classified according to palbociclib combination prescribed (palbociclib plus letrozole/aromatase inhibitor and palbociclib plus fulvestrant) at palbociclib treatment initiation were reported in this outcome measure.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Sites of Metastases Délai: At baseline (prior to initiation of palbociclib treatment)	Number of participants classified according to sites of metastases (visceral and non-visceral) were reported in this outcome measure.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Metastatic Status Délai: At baseline (prior to initiation of palbociclib treatment)	Number of participants classified according to metastatic status (denovo advanced BC and recurrent/relapse advanced BC) were reported in this outcome measure.	At baseline (prior to initiation of palbociclib treatment)
Mean Weight of the Participants Délai: At baseline (prior to initiation of palbociclib treatment)		At baseline (prior to initiation of palbociclib treatment)
Number of Participants Categorized According to Family History of Breast Cancer Délai: At baseline (prior to initiation of palbociclib treatment)	Number of participants categorized according to family history of breast cancer (Yes/No) were reported in this outcome measure.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants Categorized According to Treatment Schedule Délai: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants categorized according to treatment schedule of 3 weeks on, 1 week off (Yes) were reported in this outcome measure.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants Categorized According to Palbociclib Dose Délai: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants categorized according to palbociclib dose (75 milligram [mg], 100 mg and 125 mg) were reported in this outcome measure.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants Categorized According to Accompanying Endocrine Treatments Délai: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants categorized according to accompanying endocrine treatments were reported in this outcome measure. Accompanying endocrine treatments included: tamoxifen/NOLVADEX , toremifene / FARESTON, raloxifene / EVISTA, anastrozole / ARIMIDEX, letrozole / FEMARA, exemestane / AROMASIN, fulvestrant / FASLODEX, goserlin acetate / Zoaldex, leuprorelin /Lupron, triptorelin / Decapeptyl, degarelix / Firmagon. One participant may have received more than one endocrine treatment accompanying palbociclib treatment.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants With Dose Interruption Délai: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants with palbociclib dose interruption were reported in this outcome measure.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants With Dose Delays Délai: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants with dose delays were reported in this outcome measure.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants Who Discontinued Palbociclib Treatment Délai: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants who discontinued palbociclib treatment were reported in this outcome measure.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Duration of Palbociclib Treatment Délai: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Duration of palbociclib treatment was defined as time (in days) from first to last day in palbociclib treatment.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants According to Supportive Therapies Received During Palbociclib Combination Treatment Délai: From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants according to supportive therapies received during palbociclib combination treatment were reported in this outcome measure. Supportive therapies included: zoledronic acid, calcium supplement, alfacalcidol, letrozole, vitamin D, gabapentin, tramadol, denosumab, granisetron, morphine, filgrastim, metoclopramide, dexamethasone, domperidone, duloxetine, fulvestrant, ondansetron, prednisolone, citalopram, itopride, oxycodone, pregabalin, sertraline. One participant may have received more than one supportive therapy.	From initiation of palbociclib treatment until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
Number of Participants Categorized According to Adjuvant Therapies Délai: At baseline (prior to initiation of palbociclib treatment)	Number of participants categorized according to adjuvant therapies were reported in this outcome measure. Adjuvant therapies included: adjuvant chemotherapy, adjuvant hormonal therapy, experimental adjuvant therapy, neoadjuvant chemotherapy, neoadjuvant hormonal therapy, radiotherapy and surgery. One participant may have received more than one type of adjuvant therapy.	At baseline (prior to initiation of palbociclib treatment)
Time Between Start of Palbociclib Treatment and End of Adjuvant Therapy for Early/Locally Advanced Breast Cancer Délai: At baseline (prior to initiation of palbociclib treatment)	Time between start of palbociclib treatment and end of therapy for early/locally advanced BC was calculated as date of initiation of palbociclib treatment - date of end of therapy for early/locally advanced therapy. Time between start of palbociclib treatment and end of adjuvant therapy for early/locally advanced breast cancer was collected at baseline from participant's medical records.	At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to Therapies Received Before Palbociclib Treatment Délai: At baseline (prior to initiation of palbociclib treatment)	Number of participants according to therapies received before palbociclib treatment were reported in this outcome measure. Therapies included: MBC chemotherapy, MBC hormonal therapy (other than Palbociclib combination), combination therapy, other therapy, radiotherapy and surgery. One participant may have received more than one type of therapy. Therapies for which non-zero data were available have been reported below.	At baseline (prior to initiation of palbociclib treatment)
Duration of Therapy for Treatment Received Before Palbociclib Treatment Délai: At baseline (prior to initiation of palbociclib treatment)		At baseline (prior to initiation of palbociclib treatment)
Number of Participants According to First Subsequent Therapy Received After Palbociclib Treatment Discontinuation Délai: From palbociclib treatment discontinuation until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)	Number of participants according to first subsequent therapy received after palbociclib treatment discontinuation were reported in this outcome measure. Subsequent therapies included systemic therapy, radiotherapy, surgery and other therapy. Subsequent therapies for which non-zero data were available have been reported below.	From palbociclib treatment discontinuation until end of follow up, or until participant's withdrawal from the study or death, whichever came first (maximum up to 24 months)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Scores Délai: At 6, 12, 18 and 24 months post palbociclib treatment initiation	EORTC QLQ-30 included five functional scales (physical functioning, role, emotional, cognitive and social functioning), nine symptom scales (fatigue, nausea or vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties, and a global health status scale (GHS). The GHS/QoL scale ranged from 1=very poor to 7=excellent. All other items ranged from 1=not at all to 4=very much. A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100, with 0 being the worst and 100 being the best for GHS and functional scales, and 0 being the best and 100 being the worst for symptom scales.	At 6, 12, 18 and 24 months post palbociclib treatment initiation

Modèles de traitement et résultats cliniques des combinaisons de palbociclib dans HR+HER2-MBC (PRECIOUS)

Combinaisons de palbociclib chez les patientes atteintes d'un cancer du sein métastatique HR+/HER2- : une étude prospective non interventionnelle sur les schémas de traitement et les résultats cliniques en Afrique Moyen-Orient (PRECIOUS)