Badanie kliniczne dotyczące Rak piersi z przerzutami - Rejestr badań klinicznych

Przegląd badań

Status

Zakończony

Warunki

Rak piersi z przerzutami

Szczegółowy opis

Pacjenci z HR+/HER2- przerzutowym/miejscowo zaawansowanym BC, u których decyzja o leczeniu palbociclibem została podjęta przez lekarza prowadzącego i którzy spełniają kryteria kwalifikacji, zostaną zaproszeni do udziału w badaniu. Do badania mogą zostać włączeni pacjenci, którzy rozpoczynają leczenie palbocyklibem i letrozolem/inhibitorem aromatazy lub palbocyklibem i fulwestrantem zgodnie z zarejestrowanymi wskazaniami jako leczenie pierwszego lub drugiego rzutu raka piersi z przerzutami/miejscowo zaawansowanego raka piersi.

Zmiennymi ocenianymi w tym badaniu będą dane demograficzne pacjentów, charakterystyka kliniczna, choroby współistniejące i jednocześnie stosowane leki, historia leczenia HR+ HER2-miejscowo zaawansowanego i przerzutowego BC, obecne leczenie BC, stan sprawności (Eastern Cooperative Oncology Group (ECOG), wyniki kliniczne i QoL. Wszystkie oceny opisane w niniejszym protokole są przeprowadzane w ramach normalnej praktyki klinicznej lub wytycznych dotyczących standardowej praktyki dla populacji pacjentów i specjalizacji świadczeniodawców w krajach, w których prowadzone jest to badanie nieinterwencyjne. Wszystkie dane zebrane w tym badaniu mają na celu uchwycenie rzeczywistych wzorców leczenia i wyników dla pacjentów z HR+/HER2- przerzutowym/miejscowo zaawansowanym rakiem piersi. Do gromadzenia danych zostanie wykorzystany elektroniczny formularz opisu przypadku (eCRF). Badacze zostaną przeszkoleni podczas pierwszej wizyty na miejscu w klinice w zakresie protokołu, systemu elektronicznego gromadzenia danych (EDC) (tj. eCRF), głównego pliku ośrodka badacza (ISMF), dokumentacji i wszelkich odpowiednich procesów badawczych. Wszelkie nowe informacje istotne dla przeprowadzenia tego badania nieinterwencyjnego (NIS) zostaną przekazane personelowi medycznemu w trakcie badania. Zdalne monitorowanie danych będzie prowadzone podczas trwania badania, aby zapewnić terminowe raportowanie danych dotyczących bezpieczeństwa, integralność i spójność danych.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

185

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 90 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Pacjenci z rakiem piersi HR+/HER2- z przerzutami/miejscowo zaawansowanym rakiem piersi

Opis

Kryteria przyjęcia:

≥18 lat lub więcej z rozpoznaniem gruczolakoraka piersi z objawami przerzutów/miejscowo zaawansowanej choroby niekwalifikującej się do leczenia z zamiarem wyleczenia.
Udokumentowany guz HR+ (ER+ i/lub PR+) na podstawie lokalnych standardów
Udokumentowany guz HER2- na podstawie lokalnych standardów
Rozpocznie leczenie palbocyklibem i letrozolem/inhibitorem aromatazy lub palbocyklibem i fulwestrantem zgodnie z zarejestrowanym wskazaniem (wskazaniami), jako terapię pierwszego lub drugiego rzutu raka piersi z przerzutami/miejscowo zaawansowanego w momencie rejestracji
Pacjenci, którzy w opinii badacza są chętni i zdolni do przestrzegania regularnych wizyt w poradni
Dowód własnoręcznie podpisanego i opatrzonego datą dokumentu świadomej zgody wskazującego, że pacjent (lub prawnie akceptowany przedstawiciel) został poinformowany o wszystkich istotnych aspektach badania

Kryteria wyłączenia:

Pacjenci biorący udział w jakimkolwiek interwencyjnym badaniu klinicznym
Pacjenci aktywnie leczeni nowotworami złośliwymi innymi niż przerzutowy/miejscowo zaawansowany BC w momencie włączenia do badania
Pacjenci, którzy nie są w stanie zrozumieć charakteru badania i nie chcą podpisać świadomej zgody

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Modele obserwacyjne: Kohorta
Perspektywy czasowe: Spodziewany

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Percentage of Participants Who Were Progression Free at 6 Months Post Palbociclib Initiation Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Miary wyników drugorzędnych

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Pfizer

Śledczy

Dyrektor Studium: Pfizer CT.gov Call Center, Pfizer

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 lipca 2021

Zakończenie podstawowe (Rzeczywisty)

29 kwietnia 2025

Ukończenie studiów (Rzeczywisty)

29 kwietnia 2025

Daty rejestracji na studia

Pierwszy przesłany

8 czerwca 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 czerwca 2021

Pierwszy wysłany (Rzeczywisty)

24 czerwca 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

A5481150
PRECIOUS (Inny identyfikator: Alias Study Number)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Firma Pfizer zapewni dostęp do danych poszczególnych uczestników pozbawionych elementów umożliwiających identyfikację oraz powiązanych dokumentów badawczych (np. protokół, plan analizy statystycznej (SAP), raport z badania klinicznego (CSR)) na żądanie wykwalifikowanych badaczy i z zastrzeżeniem pewnych kryteriów, warunków i wyjątków. Więcej informacji na temat kryteriów udostępniania danych przez firmę Pfizer oraz procesu ubiegania się o dostęp można znaleźć pod adresem: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Miara wyniku	Opis środka	Ramy czasowe
Objective Response Rate (ORR) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Wzorce leczenia i wyniki kliniczne kombinacji palbocyklibu w HR+HER2-MBC (PRECIOUS)

Kombinacje palbocyklibu u pacjentów z rakiem piersi z przerzutami HR+/HER2-: nieinterwencyjne prospektywne badanie wzorców leczenia i wyników klinicznych w Afryce na Bliskim Wschodzie (PRECIOUS)