Klinisk prövning på Metastaserad bröstcancer - Kliniska prövningsregister

Studieöversikt

Status

Avslutad

Betingelser

Metastaserad bröstcancer

Detaljerad beskrivning

Patienter med HR+/HER2-metastaserande/lokalt avancerad BC vars behandlingsbeslut med palbociclib har fattats av deras behandlande läkare och som uppfyller behörighetskriterierna kommer att bjudas in att delta i studien. Patienter som påbörjar behandling med palbociclib plus letrozol/aromatashämmare eller palbociclib plus fulvestrant i enlighet med den eller de licensierade indikationerna, som första eller andra linjens behandling för metastaserande/lokalt avancerad BC vid inskrivningen kan inkluderas i studien.

Variablerna som bedöms i denna studie kommer att vara patientdemografi, kliniska egenskaper, samsjukliga tillstånd och samtidig medicinering, HR+ HER2-lokalt avancerad och metastaserad BC-behandlingshistoria, aktuell BC-behandling, prestationsstatus (Eastern Cooperative Oncology Group (ECOG), kliniska resultat och QoL. Alla bedömningar som beskrivs i detta protokoll utförs som en del av normal klinisk praxis eller riktlinjer för standardpraxis för patientpopulationen och vårdgivarens specialitet i de länder där denna icke-interventionella studie genomförs. Alla data som samlats in i denna studie är avsedda att fånga verkliga behandlingsmönster och resultat för patienter med HR+/HER2-metastaserande/lokalt avancerad BC. Ett elektroniskt fallrapportformulär (eCRF) kommer att användas för datainsamling. Utredarna kommer att utbildas med ett första besök på plats på kliniken i protokollet, elektronisk datainsamling (EDC) (dvs. eCRF), utredarplatsmasterfil (ISMF), dokumentation och eventuella tillämpliga studieprocesser. All ny information som är relevant för utförandet av denna icke-interventionsstudie (NIS) kommer att vidarebefordras till den medicinska personalen under studien. Fjärrövervakning av data kommer att utföras under studiens livslängd för att säkerställa snabb rapportering av säkerhetsdata, dataintegritet och konsistens.

Studietyp

Observationell

Inskrivning (Faktisk)

185

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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
Jordanien
- - Amman, Jordanien, 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
Saudiarabien
- - Dammam, Saudiarabien
    - King Fahad Specialist Hospital KFSH-Dammam
  - Riyadh, Saudiarabien
    - National Guard Hospital, Riyadh

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 90 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patienter med HR+/HER2- metastaserad/lokalt avancerad bröstcancer

Beskrivning

Inklusionskriterier:

≥18 år eller äldre med diagnos av adenokarcinom i bröstet med tecken på metastaserad/lokalt avancerad sjukdom som inte är mottaglig för behandling med kurativ avsikt.
Dokumenterad HR+ (ER+ och/eller PR+) tumör baserad på lokala standarder
Dokumenterad HER2-tumör baserad på lokala standarder
Kommer att initiera behandling med palbociclib plus letrozol/aromatashämmare eller palbociclib plus fulvestrant i linje med den eller de licensierade indikationerna, som första eller andra linjens behandling för metastaserande/lokalt avancerad BC vid inskrivning
Patienter som enligt utredarens uppfattning är villiga och kan följa regelbundna klinikbesök
Bevis på ett personligt undertecknat och daterat informerat samtycke som indikerar att patienten (eller en juridiskt godtagbar representant) har informerats om alla relevanta aspekter av studien

Exklusions kriterier:

Patienter som deltar i någon interventionell klinisk prövning
Patienter på aktiv behandling för andra maligniteter än metastaserande/lokalt avancerad BC vid tidpunkten för inskrivningen
Patienter som inte kan förstå studiens natur och som inte är villiga att skriva under ett informerat samtycke

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Observationsmodeller: Kohort
Tidsperspektiv: Blivande

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Percentage of Participants Who Were Progression Free at 6 Months Post Palbociclib Initiation Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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

Sekundära resultatmått

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Pfizer

Utredare

Studierektor: Pfizer CT.gov Call Center, Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 juli 2021

Primärt slutförande (Faktisk)

29 april 2025

Avslutad studie (Faktisk)

29 april 2025

Studieregistreringsdatum

Först inskickad

8 juni 2021

Först inskickad som uppfyllde QC-kriterierna

23 juni 2021

Första postat (Faktisk)

24 juni 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

A5481150
PRECIOUS (Annan identifierare: Alias Study Number)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Pfizer kommer att ge tillgång till individuella avidentifierade deltagardata och relaterade studiedokument (t.ex. protokoll, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) på begäran från kvalificerade forskare, och med förbehåll för vissa kriterier, villkor och undantag. Ytterligare information om Pfizers kriterier för datadelning och process för att begära åtkomst finns på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Resultatmått	Åtgärdsbeskrivning	Tidsram
Objective Response Rate (ORR) Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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

Behandlingsmönster och kliniska resultat av Palbociclib-kombinationer i HR+HER2-MBC (PRECIOUS)

Palbociclib Combinations in HR+/HER2- Metastatic Breast Cancer Patients: A Non-Interventional Prospective Study on the Treatment Patterns & Clinical Outcomes in Africa Middle East (PRECIOUS)