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Behandlingsmønstre og kliniske resultater af Palbociclib-kombinationer i HR+HER2-MBC (PRECIOUS)

9. juni 2026 opdateret af: Pfizer

Palbociclib-kombinationer hos HR+/HER2-patienter med metastaserende brystkræft: En ikke-interventionel prospektiv undersøgelse af behandlingsmønstre og kliniske resultater i Afrika Mellemøsten (ÆRLIGT)

Formålet med denne ikke-interventionelle multicenterundersøgelse er at give prospektive, observationsdata om patienter, der starter behandling med palbociclib-kombination for at bidrage til viden om HR+ HER2-metastatisk/lokalt fremskreden brystkræft (BC) sygdomsbehandling, dets behandlingsmønster, kliniske resultater og livskvalitet (QoL) i rutinemæssig klinisk praksis i Afrika og Mellemøstlande.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Patienter med HR+/HER2-metastatisk/lokalt fremskreden BC, hvis behandlingsbeslutning med palbociclib er blevet truffet af deres behandlende læge, og som opfylder berettigelseskriterierne, vil blive inviteret til at deltage i undersøgelsen. Patienter, der påbegynder behandling med palbociclib plus letrozol/aromatasehæmmer eller palbociclib plus fulvestrant i overensstemmelse med den eller de godkendte indikationer, som første- eller andenlinjebehandling for metastatisk/lokalt fremskreden BC ved optagelse, kan inkluderes i undersøgelsen.

Variablerne vurderet i denne undersøgelse vil være patientdemografi, kliniske karakteristika, komorbide tilstande og samtidig medicin, HR+ HER2-lokalt fremskreden og metastatisk BC-behandlingshistorie, nuværende BC-behandling, præstationsstatus (Eastern Cooperative Oncology Group (ECOG), kliniske resultater og QoL. Alle vurderinger beskrevet i denne protokol udføres som en del af normal klinisk praksis eller standard praksisretningslinjer for patientpopulationen og sundhedsudbyderens speciale i de lande, hvor denne ikke-interventionelle undersøgelse udføres. Alle data indsamlet i denne undersøgelse er beregnet til at fange de virkelige behandlingsmønstre og resultater for patienter med HR+/HER2-metastatisk/lokalt fremskreden BC. En elektronisk sagsrapportformular (eCRF) vil blive brugt til dataindsamling. Efterforskere vil blive trænet med et indledende on-site besøg på klinikken i protokollen, elektronisk datafangst (EDC) system (dvs. eCRF), investigator site master file (ISMF), dokumentation og eventuelle relevante undersøgelsesprocesser. Alle nye oplysninger, der er relevante for udførelsen af ​​denne ikke-interventionelle undersøgelse (NIS), vil blive videresendt til det medicinske personale under undersøgelsen. Fjerndataovervågning vil blive udført i løbet af undersøgelsen for at sikre rettidig rapportering af sikkerhedsdata, dataintegritet og konsistens.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

185

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
      • Alexandria, Egypten
        • Alexandria School of Medicine/Clinical Research Center CRC
      • Cairo, Egypten, 11796
        • National Cancer Institute
      • Cairo, Egypten
        • Ain shams university hospital
      • Cairo, Egypten, 11745
        • Dar El Salam Oncology Hospital
  • Jordan
      • Amman, Jordan, 11941
        • King Hussein Cancer Center
  • 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)
  • Qatar
      • Doha, Qatar
        • Hamad Medical Corporation
  • Saudi Arabien
      • Dammam, Saudi Arabien
        • King Fahad Specialist Hospital KFSH-Dammam
      • Riyadh, Saudi Arabien
        • National Guard Hospital, Riyadh

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patienter med HR+/HER2- metastatisk/lokalt fremskreden brystkræft

Beskrivelse

Inklusionskriterier:

  1. ≥18 år eller ældre med diagnosen adenocarcinom i brystet med tegn på metastatisk/lokalt fremskreden sygdom, der ikke kan behandles med helbredende hensigter.
  2. Dokumenteret HR+ (ER+ og/eller PR+) tumor baseret på lokale standarder
  3. Dokumenteret HER2-tumor baseret på lokale standarder
  4. Vil påbegynde behandling med palbociclib plus letrozol/aromatasehæmmer eller palbociclib plus fulvestrant i overensstemmelse med den eller de godkendte indikationer, som første- eller andenlinjebehandling for metastatisk/lokalt fremskreden BC ved indskrivning
  5. Patienter, der efter investigators opfattelse er villige og i stand til at overholde regelmæssige klinikbesøg
  6. Bevis på et personligt underskrevet og dateret informeret samtykkedokument, der indikerer, at patienten (eller en juridisk acceptabel repræsentant) er blevet informeret om alle relevante aspekter af undersøgelsen

Ekskluderingskriterier:

  1. Patienter, der deltager i ethvert interventionelt klinisk forsøg
  2. Patienter i aktiv behandling for andre maligne sygdomme end metastatisk/lokalt fremskreden BC på tidspunktet for indskrivning
  3. Patienter, der ikke er i stand til at forstå undersøgelsens karakter og ikke er villige til at underskrive et informeret samtykke

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Were Progression Free at 6 Months Post Palbociclib Initiation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. juli 2021

Primær færdiggørelse (Faktiske)

29. april 2025

Studieafslutning (Faktiske)

29. april 2025

Datoer for studieregistrering

Først indsendt

8. juni 2021

Først indsendt, der opfyldte QC-kriterier

23. juni 2021

Først opslået (Faktiske)

24. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A5481150
  • PRECIOUS (Anden identifikator: Alias Study Number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Pfizer vil give adgang til individuelle afidentificerede deltagerdata og relaterede undersøgelsesdokumenter (f.eks. protokol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) efter anmodning fra kvalificerede forskere og underlagt visse kriterier, betingelser og undtagelser. Yderligere detaljer om Pfizers datadelingskriterier og proces for at anmode om adgang kan findes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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