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HR+HER2-MBCにおけるパルボシクリブ併用療法の治療パターンと臨床転帰 (PRECIOUS)

2026年6月9日 更新者：Pfizer

HR+/HER2- 転移性乳がん患者におけるパルボシクリブの併用：アフリカ中東における治療パターンと臨床転帰に関する非介入前向き研究 (PRECIOUS)

この非介入多施設研究の目的は、パルボシクリブの併用による治療を開始する患者に関する前向き観察データを提供し、HR+ HER2 転移性/局所進行乳癌 (BC) の疾患管理、その治療パターン、臨床転帰に関する知識に貢献することです。およびアフリカおよび中東諸国の日常的な臨床診療における生活の質 (QoL)。

調査の概要

状態

完了

条件

詳細な説明

HR + / HER2-転移性/局所進行性BCの患者で、パルボシクリブによる治療の決定が担当医によって行われ、適格基準を満たす患者は、研究に参加するよう招待されます。 -登録時に転移性/局所進行性BCに対する一次または二次治療として、パルボシクリブとレトロゾール/アロマターゼ阻害剤またはパルボシクリブとフルベストラントによる治療を開始する患者は、登録時に研究に含まれる場合があります。

この研究で評価される変数は、患者の人口統計、臨床的特徴、併存疾患および併用薬、HR + HER2-局所進行および転移性BC治療歴、現在のBC治療、パフォーマンスステータス（Eastern Cooperative Oncology Group（ECOG）、臨床転帰、およびQoL。 このプロトコルで説明されているすべての評価は、この非介入研究が実施されている国の患者集団および医療提供者の専門分野の通常の臨床診療または標準診療ガイドラインの一部として実行されます。 この研究で収集されたすべてのデータは、HR+/HER2-転移性/局所進行BC患者の実際の治療パターンと転帰を把握することを目的としています。 データ収集には、電子症例報告フォーム (eCRF) が使用されます。 治験責任医師は、プロトコル、電子データ取得 (EDC) システム (すなわち、eCRF)、治験責任医師サイトマスターファイル (ISMF)、ドキュメンテーション、および該当するすべての治験プロセスについて、クリニックへの最初のオンサイト訪問でトレーニングを受けます。 この非介入研究（NIS）の実施に関連する新しい情報は、研究中に医療スタッフに転送されます。 安全性データ、データの完全性および一貫性のタイムリーな報告を確実にするために、研究期間中、遠隔データモニタリングが実施されます。

研究の種類

観察的

入学 (実際)

185

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • エジプト
      • Alexandria、エジプト
        • Alexandria School of Medicine/Clinical Research Center CRC
      • Cairo、エジプト、11796
        • National Cancer Institute
      • Cairo、エジプト
        • Ain Shams University Hospital
      • Cairo、エジプト、11745
        • Dar El Salam Oncology Hospital
  • カタール
      • Doha、カタール
        • Hamad Medical Corporation
  • サウジアラビア
      • Dammam、サウジアラビア
        • King Fahad Specialist Hospital KFSH-Dammam
      • Riyadh、サウジアラビア
        • National Guard Hospital, Riyadh
  • ヨルダン
      • Amman、ヨルダン、11941
        • King Hussein Cancer Center
  • レバノン
      • Beirut、レバノン
        • American University of Beirut Medical Center
      • Beirut、レバノン
        • Hôtel Dieu de France (HDF)
      • Jdeidé - Metn、レバノン
        • Saint Joseph Hospital - Cancer Centers of Colorado
      • Sidon、レバノン
        • Hammoud Hospital University Medical Center (HHUMC)

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～90年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

HR+/HER2-転移性/局所進行乳がん患者

説明

包含基準:

  1. -乳房の腺癌の診断を受けた18歳以上で、転移性/局所進行性疾患の証拠があり、治癒を目的とした治療を受けにくい。
  2. -地域の基準に基づいて文書化されたHR +（ER +および/またはPR +）腫瘍
  3. 地域の基準に基づいて文書化された HER2- 腫瘍
  4. -登録時の転移性/局所進行BCの第一選択または第二選択療法として、承認された適応症に沿って、パルボシクリブとレトロゾール/アロマターゼ阻害剤またはパルボシクリブとフルベストラントによる治療を開始します
  5. -治験責任医師の意見では、定期的な診療所への訪問を喜んで順守できる患者
  6. 患者（または法的に認められた代理人）が研究のすべての関連する側面について知らされたことを示す、個人的に署名され、日付が記入されたインフォームドコンセント文書の証拠

除外基準:

  1. -介入臨床試験に参加している患者
  2. -登録時に転移性/局所進行性BC以外の悪性腫瘍の積極的な治療を受けている患者
  3. -研究の性質を理解することができず、インフォームドコンセントに署名することを望まない患者

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：コホート
  • 時間の展望：見込みのある

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Percentage of Participants Who Were Progression Free at 6 Months Post Palbociclib Initiation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Objective Response Rate (ORR)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pfizer

捜査官

  • スタディディレクター：Pfizer CT.gov Call Center、Pfizer

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年7月15日

一次修了 (実際)

2025年4月29日

研究の完了 (実際)

2025年4月29日

試験登録日

最初に提出

2021年6月8日

QC基準を満たした最初の提出物

2021年6月23日

最初の投稿 (実際)

2021年6月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月10日

QC基準を満たした最後の更新が送信されました

2026年6月9日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • A5481150
  • PRECIOUS (その他の識別子：Alias Study Number)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

ファイザーは、匿名化された個々の参加者データおよび関連する研究文書へのアクセスを提供します (例: プロトコル、統計分析計画 (SAP)、臨床研究報告書 (CSR)) は、有資格の研究者からの要求に応じて、特定の基準、条件、および例外に従います。 ファイザーのデータ共有基準とアクセス要求プロセスの詳細については、https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests をご覧ください。

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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