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Behandlingsmønstre og kliniske resultater av Palbociclib-kombinasjoner i HR+HER2-MBC (PRECIOUS)

9. juni 2026 oppdatert av: Pfizer

Palbociclib-kombinasjoner i HR+/HER2- Metastaserende brystkreftpasienter: En ikke-intervensjonell prospektiv studie av behandlingsmønstre og kliniske resultater i Afrika Midtøsten (PRESIOUS)

Målet med denne ikke-intervensjonelle multisenterstudien er å gi prospektive, observasjonsdata om pasienter som starter behandling med palbociclib-kombinasjon for å bidra til kunnskapen om HR+ HER2-metastatisk/lokalt avansert brystkreft (BC) sykdomsbehandling, dets behandlingsmønster, kliniske resultater og livskvalitet (QoL) i rutinemessig klinisk praksis i Afrika og Midtøsten-land.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Pasienter med HR+/HER2-metastatisk/lokalt avansert BC hvis behandlingsbeslutning med palbociclib er tatt av deres behandlende lege og som oppfyller kvalifikasjonskriteriene, vil bli invitert til å delta i studien. Pasienter som starter behandling med palbociclib pluss letrozol/aromatasehemmer eller palbociclib pluss fulvestrant i tråd med den(e) lisensierte indikasjonen(e), som første- eller andrelinjebehandling for metastatisk/lokalt avansert BC ved innrullering kan inkluderes i studien.

Variablene som vurderes i denne studien vil være pasientdemografi, kliniske egenskaper, komorbide tilstander og samtidige medisiner, HR+ HER2-lokalt avansert og metastatisk BC-behandlingshistorie, nåværende BC-behandling, prestasjonsstatus (Eastern Cooperative Oncology Group (ECOG), kliniske utfall, og QoL. Alle vurderinger beskrevet i denne protokollen utføres som en del av normal klinisk praksis eller standard praksisretningslinjer for pasientpopulasjonen og spesialitet fra helsepersonell i landene der denne ikke-intervensjonelle studien utføres. Alle data som samles inn i denne studien er ment å fange opp de virkelige behandlingsmønstrene og resultatene for pasienter med HR+/HER2-metastatisk/lokalt avansert BC. Et elektronisk saksrapportskjema (eCRF) vil bli brukt for datainnsamling. Etterforskere vil bli opplært med et første besøk på stedet til klinikken på protokollen, elektronisk datafangst (EDC)-system (dvs. eCRF), etterforskersteds masterfil (ISMF), dokumentasjon og eventuelle aktuelle studieprosesser. All ny informasjon som er relevant for utførelsen av denne ikke-intervensjonelle studien (NIS) vil bli videresendt til det medisinske personalet under studien. Fjernovervåking av data vil bli utført i løpet av studiens levetid for å sikre rettidig rapportering av sikkerhetsdata, dataintegritet og konsistens.

Studietype

Observasjonsmessig

Registrering (Faktiske)

185

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Egypt
      • Alexandria, Egypt
        • Alexandria School of Medicine/Clinical Research Center CRC
      • Cairo, Egypt, 11796
        • National Cancer Institute
      • Cairo, Egypt
        • Ain Shams University Hospital
      • Cairo, Egypt, 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-Arabia
      • Dammam, Saudi-Arabia
        • King Fahad Specialist Hospital KFSH-Dammam
      • Riyadh, Saudi-Arabia
        • National Guard Hospital, Riyadh

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Pasienter med HR+/HER2-metastatisk/lokalt avansert brystkreft

Beskrivelse

Inklusjonskriterier:

  1. ≥18 år eller eldre med diagnosen adenokarsinom i brystet med tegn på metastatisk/lokalt avansert sykdom som ikke kan behandles med kurativ hensikt.
  2. Dokumentert HR+ (ER+ og/eller PR+) svulst basert på lokale standarder
  3. Dokumentert HER2- svulst basert på lokale standarder
  4. Vil starte behandling med palbociclib pluss letrozol/aromatasehemmer eller palbociclib pluss fulvestrant i tråd med den(e) lisensierte indikasjonen(e), som første- eller andrelinjebehandling for metastatisk/lokalt avansert BC ved påmelding
  5. Pasienter som etter utrederens mening er villige og i stand til å etterkomme vanlige klinikkbesøk
  6. Bevis på et personlig signert og datert informert samtykkedokument som indikerer at pasienten (eller en juridisk akseptabel representant) har blitt informert om alle relevante aspekter av studien

Ekskluderingskriterier:

  1. Pasienter som deltar i enhver intervensjonell klinisk studie
  2. Pasienter på aktiv behandling for andre maligniteter enn metastatisk/lokalt avansert BC på tidspunktet for innskrivning
  3. Pasienter som ikke er i stand til å forstå studiens natur og ikke er villige til å signere et informert samtykke

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Etterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juli 2021

Primær fullføring (Faktiske)

29. april 2025

Studiet fullført (Faktiske)

29. april 2025

Datoer for studieregistrering

Først innsendt

8. juni 2021

Først innsendt som oppfylte QC-kriteriene

23. juni 2021

Først lagt ut (Faktiske)

24. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Pfizer vil gi tilgang til individuelle avidentifiserte deltakerdata og relaterte studiedokumenter (f.eks. protokoll, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) på forespørsel fra kvalifiserte forskere, og underlagt visse kriterier, betingelser og unntak. Ytterligere detaljer om Pfizers datadelingskriterier og prosess for å be om tilgang finnes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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