Klinische proef op Uitgezaaide borstkanker - Register voor klinische proeven

Studie Overzicht

Toestand

Voltooid

Conditie

Uitgezaaide borstkanker

Gedetailleerde beschrijving

Patiënten met HR+/HER2- gemetastaseerd/lokaal gevorderd BC bij wie de behandelingsbeslissing met palbociclib is genomen door hun behandelend arts en die voldoen aan de criteria om in aanmerking te komen, zullen worden uitgenodigd om deel te nemen aan het onderzoek. Patiënten die een behandeling starten met palbociclib plus letrozol/aromataseremmer of palbociclib plus fulvestrant in overeenstemming met de goedgekeurde indicatie(s), als eerste- of tweedelijnsbehandeling voor gemetastaseerd/lokaal gevorderd BC bij inschrijving, kunnen in het onderzoek worden opgenomen.

De variabelen die in deze studie worden beoordeeld, zijn demografische gegevens van de patiënt, klinische kenmerken, comorbide aandoeningen en gelijktijdige medicatie, HR+ HER2-lokaal geavanceerde en gemetastaseerde BC-behandelingsgeschiedenis, huidige BC-behandeling, prestatiestatus (Eastern Cooperative Oncology Group (ECOG), klinische uitkomsten, en KvL. Alle beoordelingen die in dit protocol worden beschreven, worden uitgevoerd als onderdeel van de normale klinische praktijk of standaardpraktijkrichtlijnen voor de patiëntenpopulatie en het specialisme van de zorgverlener in de landen waar dit niet-interventionele onderzoek wordt uitgevoerd. Alle gegevens die in dit onderzoek worden verzameld, zijn bedoeld om de werkelijke behandelingspatronen en resultaten vast te leggen voor patiënten met HR+/HER2-gemetastaseerde/lokaal gevorderde BC. Voor het verzamelen van gegevens zal een elektronisch casusrapportageformulier (eCRF) worden gebruikt. Onderzoekers zullen worden getraind met een eerste bezoek ter plaatse aan de kliniek over het protocol, het systeem voor het vastleggen van elektronische gegevens (EDC) (d.w.z. eCRF), het hoofdbestand van de onderzoekersite (ISMF), documentatie en eventuele toepasselijke onderzoeksprocessen. Alle nieuwe informatie die relevant is voor de uitvoering van deze niet-interventionele studie (NIS) zal tijdens de studie worden doorgestuurd naar de medische staf. Gegevensbewaking op afstand zal worden uitgevoerd gedurende de looptijd van het onderzoek om te zorgen voor tijdige rapportage van veiligheidsgegevens, gegevensintegriteit en consistentie.

Studietype

Observationeel

Inschrijving (Werkelijk)

185

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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
Jordanië
- - Amman, Jordanië, 11941
    - King Hussein Cancer Center
Katar
- - Doha, Katar
    - Hamad Medical Corporation
Libanon
- - Beirut, Libanon
    - American University of Beirut Medical Center
  - Beirut, Libanon
    - Hôtel Dieu de France (HDF)
  - Jdeidé - Metn, Libanon
    - Saint Joseph Hospital - Cancer Centers of Colorado
  - Sidon, Libanon
    - Hammoud Hospital University Medical Center (HHUMC)
Saoedi-Arabië
- - Dammam, Saoedi-Arabië
    - King Fahad Specialist Hospital KFSH-Dammam
  - Riyadh, Saoedi-Arabië
    - National Guard Hospital, Riyadh

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 90 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patiënten met HR+/HER2- gemetastaseerde/lokaal gevorderde borstkanker

Beschrijving

Inclusiecriteria:

≥18 jaar of ouder met de diagnose adenocarcinoom van de borst met bewijs van gemetastaseerde/lokaal gevorderde ziekte die niet vatbaar is voor behandeling met curatieve bedoelingen.
Gedocumenteerde HR+ (ER+ en/of PR+) tumor op basis van lokale standaarden
Gedocumenteerde HER2-tumor op basis van lokale standaarden
Start de behandeling met palbociclib plus letrozol/aromataseremmer of palbociclib plus fulvestrant in overeenstemming met de geregistreerde indicatie(s), als eerste- of tweedelijnsbehandeling voor gemetastaseerde/lokaal gevorderde BC bij inschrijving
Patiënten die naar de mening van de onderzoeker bereid en in staat zijn om te voldoen aan reguliere kliniekbezoeken
Bewijs van een persoonlijk ondertekend en gedateerd document voor geïnformeerde toestemming waaruit blijkt dat de patiënt (of een wettelijk aanvaardbare vertegenwoordiger) op de hoogte is gebracht van alle relevante aspecten van het onderzoek

Uitsluitingscriteria:

Patiënten die deelnemen aan een interventionele klinische studie
Patiënten die actief worden behandeld voor maligniteiten anders dan gemetastaseerd/lokaal gevorderd BC op het moment van inschrijving
Patiënten die de aard van het onderzoek niet kunnen begrijpen en niet bereid zijn een geïnformeerde toestemming te ondertekenen

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: Cohort
Tijdsperspectieven: Prospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Percentage of Participants Who Were Progression Free at 6 Months Post Palbociclib Initiation Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Secundaire uitkomstmaten

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Pfizer

Onderzoekers

Studie directeur: Pfizer CT.gov Call Center, Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 juli 2021

Primaire voltooiing (Werkelijk)

29 april 2025

Studie voltooiing (Werkelijk)

29 april 2025

Studieregistratiedata

Eerst ingediend

8 juni 2021

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2021

Eerst geplaatst (Werkelijk)

24 juni 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

9 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

A5481150
PRECIOUS (Andere identificatie: Alias Study Number)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Pfizer zal toegang verlenen tot de gegevens van individuele geanonimiseerde deelnemers en gerelateerde studiedocumenten (bijv. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) op verzoek van gekwalificeerde onderzoekers en onder voorbehoud van bepaalde criteria, voorwaarden en uitzonderingen. Meer details over Pfizer's criteria voor het delen van gegevens en het proces voor het aanvragen van toegang zijn te vinden op: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Objective Response Rate (ORR) Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Behandelingspatronen en klinische resultaten van Palbociclib-combinaties in HR+HER2-MBC (PRECIOUS)

Palbociclib-combinaties bij HR+/HER2- gemetastaseerde borstkankerpatiënten: een niet-interventioneel prospectief onderzoek naar de behandelingspatronen en klinische resultaten in Afrika, het Midden-Oosten (PRECIOUS)