- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04937660
Palbociclib-yhdistelmien hoitomallit ja kliiniset tulokset HR+HER2-MBC:ssä (PRECIOUS)
Palbosiklib-yhdistelmät HR+/HER2-metastaattisilla rintasyöpäpotilailla: Ei-interventiivinen tulevaisuustutkimus Afrikan hoitotavoista ja kliinisistä tuloksista Lähi-idässä (ARVO)
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Potilaat, joilla on HR+/HER2- metastaattinen/paikallisesti edennyt BC, joiden hoitava lääkäri on tehnyt hoitopäätöksen palbosiklibillä ja jotka täyttävät kelpoisuuskriteerit, kutsutaan osallistumaan tutkimukseen. Tutkimukseen voidaan ottaa mukaan potilaat, jotka aloittavat hoidon palbosiklibillä ja letrotsoli/aromataasin estäjällä tai palbosiklibillä ja fulvestrantilla luvanvaraisten käyttöaiheiden mukaisesti ensimmäisen tai toisen linjan hoitona metastaattisen/paikallisesti edenneen BC:n hoitoon.
Tässä tutkimuksessa arvioitavia muuttujia ovat potilaan demografiset tiedot, kliiniset ominaisuudet, samanaikaiset sairaudet ja samanaikaiset lääkkeet, HR+ HER2 -paikallisesti pitkälle edennyt ja metastaattinen BC-hoitohistoria, nykyinen BC-hoito, suorituskykytila (Eastern Cooperative Oncology Group (ECOG), kliiniset tulokset ja QoL. Kaikki tässä protokollassa kuvatut arvioinnit suoritetaan osana normaalia kliinistä käytäntöä tai vakiokäytäntöä potilasväestölle ja terveydenhuollon tarjoajan erikoisalalle maissa, joissa tämä ei-interventiotutkimus suoritetaan. Kaikki tässä tutkimuksessa kerätyt tiedot on tarkoitettu ottamaan huomioon todelliset hoitotavat ja tulokset potilailla, joilla on HR+/HER2- metastaattinen/paikallisesti edennyt BC. Tiedonkeruussa käytetään sähköistä tapausraporttilomaketta (eCRF). Tutkijat koulutetaan ensimmäisellä käynnillä klinikalla protokollaan, elektroniseen tiedonkeruujärjestelmään (EDC) (eli eCRF), tutkijapaikan päätiedostoon (ISMF), dokumentaatioon ja kaikkiin soveltuviin tutkimusprosesseihin. Kaikki uudet tiedot, jotka liittyvät tämän ei-interventiotutkimuksen (NIS) suorittamiseen, välitetään lääketieteelliselle henkilökunnalle tutkimuksen aikana. Tietojen etäseurantaa suoritetaan tutkimuksen keston ajan turvallisuustietojen oikea-aikaisen raportoinnin, tietojen eheyden ja johdonmukaisuuden varmistamiseksi.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
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Alexandria, Egypti
- Alexandria School of Medicine/Clinical Research Center CRC
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Cairo, Egypti, 11796
- National Cancer Institute
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Cairo, Egypti
- Ain Shams University Hospital
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Cairo, Egypti, 11745
- Dar El Salam Oncology Hospital
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Amman, Jordania, 11941
- King Hussein Cancer Center
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Beirut, Libanon
- American University of Beirut Medical Center
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Beirut, Libanon
- Hôtel Dieu de France (HDF)
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Jdeidé - Metn, Libanon
- Saint Joseph Hospital - Cancer Centers of Colorado
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Sidon, Libanon
- Hammoud Hospital University Medical Center (HHUMC)
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Doha, Qatar
- Hamad Medical Corporation
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Dammam, Saudi-Arabia
- King Fahad Specialist Hospital KFSH-Dammam
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Riyadh, Saudi-Arabia
- National Guard Hospital, Riyadh
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Sisällyttämiskriteerit:
- ≥18-vuotiaat tai vanhemmat, joilla on diagnosoitu rintojen adenokarsinooma ja merkkejä metastaattisesta/paikallisesti edenneestä taudista, jota ei voida hoitaa parantavalla tarkoituksella.
- Dokumentoitu HR+ (ER+ ja/tai PR+) kasvain paikallisten standardien perusteella
- Dokumentoitu HER2-kasvain paikallisten standardien perusteella
- Aloita hoidon palbosiklibillä plus letrotsoli/aromataasin estäjä tai palbosiclib plus fulvestrant lisensoitujen käyttöaiheiden mukaisesti ensimmäisen tai toisen linjan hoitona metastaattisen/paikallisesti edenneen BC:n hoitoon ilmoittautumisen yhteydessä
- Potilaat, jotka tutkijan mielestä ovat halukkaita ja kykeneviä noudattamaan säännöllisiä klinikkakäyntejä
- Todiste henkilökohtaisesti allekirjoitetusta ja päivätystä tietoon perustuvasta suostumusasiakirjasta, joka osoittaa, että potilaalle (tai laillisesti hyväksyttävälle edustajalle) on tiedotettu kaikista tutkimuksen oleellisista näkökohdista
Poissulkemiskriteerit:
- Potilaat, jotka osallistuvat mihin tahansa kliiniseen interventiotutkimukseen
- Potilaat, jotka saavat aktiivista hoitoa muihin pahanlaatuisiin kasvaimiin kuin etäpesäkkeisiin/paikallisesti edenneeseen BC:hen ilmoittautumishetkellä
- Potilaat, jotka eivät pysty ymmärtämään tutkimuksen luonnetta eivätkä ole halukkaita allekirjoittamaan tietoon perustuvaa suostumusta
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: Kohortti
- Aikanäkymät: Tulevaisuuden
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Percentage of Participants Who Were Progression Free at 6 Months Post Palbociclib Initiation
Aikaikkuna: At 6 months from the date of palbociclib initiation in routine clinical practice
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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.
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At 6 months from the date of palbociclib initiation in routine clinical practice
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Percentage of Participants Who Were Progression Free at 12 Months Post Palbociclib Initiation
Aikaikkuna: At 12 months from the date of palbociclib initiation in routine clinical practice
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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.
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At 12 months from the date of palbociclib initiation in routine clinical practice
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Percentage of Participants Who Were Progression Free at 18 Months Post Palbociclib Initiation
Aikaikkuna: At 18 months from the date of palbociclib initiation in routine clinical practice
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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.
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At 18 months from the date of palbociclib initiation in routine clinical practice
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Percentage of Participants Who Were Progression Free at 24 Months Post Palbociclib Initiation
Aikaikkuna: At 24 months from the date of palbociclib initiation in routine clinical practice
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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.
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At 24 months from the date of palbociclib initiation in routine clinical practice
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Percentage of Participants Who Were Alive at 1 Year Post Palbociclib Initiation
Aikaikkuna: At 1 year from the date of palbociclib initiation in routine clinical practice
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Percentage of participants who were alive at 1 year post palbociclib initiation were reported in this outcome measure.
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At 1 year from the date of palbociclib initiation in routine clinical practice
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Percentage of Participants Who Were Alive at 2 Years Post Palbociclib Initiation
Aikaikkuna: At 2 year from the date of palbociclib initiation in routine clinical practice
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Percentage of participants who were alive at 2 years post palbociclib initiation were reported in this outcome measure.
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At 2 year from the date of palbociclib initiation in routine clinical practice
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Objective Response Rate (ORR)
Aikaikkuna: 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)
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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.
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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)
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Time From Initial Breast Cancer Diagnosis to Recurrence of Breast Cancer
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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Data for time from initial breast cancer diagnosis to recurrence of breast cancer was collected at baseline from participants medical records.
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At baseline (prior to initiation of palbociclib treatment)
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Number of Participants According to Stage of Breast Cancer
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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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.
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At baseline (prior to initiation of palbociclib treatment)
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Number of Participants According to Node Status
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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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.
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At baseline (prior to initiation of palbociclib treatment)
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Number of Participants According to Menopausal Status
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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Number of participants classified according to menopausal status were reported in this outcome measure.
Menopausal status included: pre-menopausal and post-menopausal.
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At baseline (prior to initiation of palbociclib treatment)
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Number of Participants According to Prescribed Palbociclib Combination
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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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.
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At baseline (prior to initiation of palbociclib treatment)
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Number of Participants According to Sites of Metastases
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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Number of participants classified according to sites of metastases (visceral and non-visceral) were reported in this outcome measure.
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At baseline (prior to initiation of palbociclib treatment)
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Number of Participants According to Metastatic Status
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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Number of participants classified according to metastatic status (denovo advanced BC and recurrent/relapse advanced BC) were reported in this outcome measure.
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At baseline (prior to initiation of palbociclib treatment)
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Mean Weight of the Participants
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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At baseline (prior to initiation of palbociclib treatment)
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Number of Participants Categorized According to Family History of Breast Cancer
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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Number of participants categorized according to family history of breast cancer (Yes/No) were reported in this outcome measure.
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At baseline (prior to initiation of palbociclib treatment)
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Number of Participants Categorized According to Treatment Schedule
Aikaikkuna: 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)
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Number of participants categorized according to treatment schedule of 3 weeks on, 1 week off (Yes) were reported in this outcome measure.
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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)
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Number of Participants Categorized According to Palbociclib Dose
Aikaikkuna: 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)
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Number of participants categorized according to palbociclib dose (75 milligram [mg], 100 mg and 125 mg) were reported in this outcome measure.
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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)
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Number of Participants Categorized According to Accompanying Endocrine Treatments
Aikaikkuna: 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)
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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.
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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)
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Number of Participants With Dose Interruption
Aikaikkuna: 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)
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Number of participants with palbociclib dose interruption were reported in this outcome measure.
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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)
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Number of Participants With Dose Delays
Aikaikkuna: 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)
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Number of participants with dose delays were reported in this outcome measure.
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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)
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Number of Participants Who Discontinued Palbociclib Treatment
Aikaikkuna: 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)
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Number of participants who discontinued palbociclib treatment were reported in this outcome measure.
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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)
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Duration of Palbociclib Treatment
Aikaikkuna: 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)
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Duration of palbociclib treatment was defined as time (in days) from first to last day in palbociclib treatment.
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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)
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Number of Participants According to Supportive Therapies Received During Palbociclib Combination Treatment
Aikaikkuna: 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)
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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.
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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)
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Number of Participants Categorized According to Adjuvant Therapies
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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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.
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At baseline (prior to initiation of palbociclib treatment)
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Time Between Start of Palbociclib Treatment and End of Adjuvant Therapy for Early/Locally Advanced Breast Cancer
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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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.
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At baseline (prior to initiation of palbociclib treatment)
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Number of Participants According to Therapies Received Before Palbociclib Treatment
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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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.
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At baseline (prior to initiation of palbociclib treatment)
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Duration of Therapy for Treatment Received Before Palbociclib Treatment
Aikaikkuna: At baseline (prior to initiation of palbociclib treatment)
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At baseline (prior to initiation of palbociclib treatment)
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Number of Participants According to First Subsequent Therapy Received After Palbociclib Treatment Discontinuation
Aikaikkuna: 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)
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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.
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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)
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European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Scores
Aikaikkuna: At 6, 12, 18 and 24 months post palbociclib treatment initiation
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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.
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At 6, 12, 18 and 24 months post palbociclib treatment initiation
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Pfizer CT.gov Call Center, Pfizer
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- A5481150
- PRECIOUS (Muu tunniste: Alias Study Number)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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