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HR+HER2-MBC에서 팔보시클립 병용요법의 치료 패턴 및 임상 결과 (PRECIOUS)

2026년 6월 9일 업데이트: Pfizer

HR+/HER2- 전이성 유방암 환자의 팔보시클립 조합: 아프리카 중동의 치료 패턴 및 임상 결과에 대한 비간섭 전향적 연구(PRECIOUS)

이 비중재적 다기관 연구의 목적은 HR+ HER2-전이성/국소 진행성 유방암(BC) 질병 관리, 치료 패턴, 임상 결과에 대한 지식에 기여하기 위해 팔보시클립 조합으로 치료를 시작하는 환자에 대한 전향적 관찰 데이터를 제공하는 것입니다. 아프리카 및 중동 국가의 일상적인 임상 진료에서 삶의 질(QoL).

연구 개요

상태

완전한

정황

상세 설명

HR+/HER2- 전이성/국소 진행성 BC 환자 중 치료 의사가 팔보시클립으로 치료 결정을 내렸고 적격성 기준을 충족하는 환자가 연구에 참여하도록 초대됩니다. 등록 시 전이성/국소 진행성 BC에 대한 1차 또는 2차 요법으로 허가된 적응증에 따라 팔보시클립 + 레트로졸/아로마타제 억제제 또는 팔보시클립 + 풀베스트란트로 치료를 시작하는 환자가 연구에 포함될 수 있습니다.

이 연구에서 평가된 변수는 환자 인구 통계, 임상 특성, 동반이환 상태 및 병용 약물, HR+ HER2-국소 진행성 및 전이성 BC 치료 이력, 현재 BC 치료, 수행 상태(ECOG(Eastern Cooperative Oncology Group), 임상 결과 및 QoL. 이 프로토콜에 설명된 모든 평가는 이 비개입 연구가 수행되는 국가의 환자 집단 및 의료 제공자 전문 분야에 대한 일반 임상 실습 또는 표준 실습 지침의 일부로 수행됩니다. 이 연구에서 수집된 모든 데이터는 HR+/HER2- 전이성/국소적으로 진행된 BC 환자의 실제 치료 패턴 및 결과를 포착하기 위한 것입니다. 전자 사례 보고서 양식(eCRF)이 데이터 수집에 사용됩니다. 조사자는 프로토콜, 전자 데이터 캡처(EDC) 시스템(즉, eCRF), 조사자 현장 마스터 파일(ISMF), 문서 및 모든 적용 가능한 연구 프로세스에 대한 클리닉의 초기 현장 방문을 통해 교육을 받을 것입니다. 이 비개입 연구(NIS)의 수행과 관련된 모든 새로운 정보는 연구 중에 의료진에게 전달됩니다. 원격 데이터 모니터링은 안전 데이터, 데이터 무결성 및 일관성의 적시 보고를 보장하기 위해 연구 기간 동안 수행됩니다.

연구 유형

관찰

등록 (실제)

185

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

HR+/HER2- 전이성/국소 진행성 유방암 환자

설명

포함 기준:

  1. 치료 의도가 있는 치료가 불가능한 전이성/국소 진행성 질환의 증거가 있는 유방 선암 진단을 받은 18세 이상.
  2. 현지 표준에 따라 기록된 HR+(ER+ 및/또는 PR+) 종양
  3. 현지 표준에 따라 문서화된 HER2- 종양
  4. 등록 시 전이성/국소 진행성 BC에 대한 1차 또는 2차 요법으로 허가된 적응증에 따라 팔보시클립 + 레트로졸/아로마타제 억제제 또는 팔보시클립 + 풀베스트란트로 치료를 시작합니다.
  5. 연구자의 의견에 따라 정기적인 진료소 방문을 준수할 의지와 능력이 있는 환자
  6. 환자(또는 법적으로 허용되는 대리인)가 연구의 모든 관련 측면에 대해 통보받았음을 나타내는 개인적으로 서명되고 날짜가 기재된 사전 동의 문서의 증거

제외 기준:

  1. 중재 임상 시험에 참여하는 환자
  2. 등록 당시 전이성/국소 진행성 BC 이외의 악성 종양에 대한 활성 치료를 받고 있는 환자
  3. 연구의 성격을 이해할 수 없고 정보에 입각한 동의서에 서명하기를 꺼리는 환자

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 보병대
  • 시간 관점: 유망한

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Who Were Progression Free at 6 Months Post Palbociclib Initiation
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate (ORR)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

수사관

  • 연구 책임자: Pfizer CT.gov Call Center, Pfizer

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 7월 15일

기본 완료 (실제)

2025년 4월 29일

연구 완료 (실제)

2025년 4월 29일

연구 등록 날짜

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2021년 6월 8일

QC 기준을 충족하는 최초 제출

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처음 게시됨 (실제)

2021년 6월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A5481150
  • PRECIOUS (기타 식별자: Alias Study Number)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

화이자는 식별되지 않은 개별 참가자 데이터 및 관련 연구 문서(예: 프로토콜, 통계 분석 계획(SAP), 임상 연구 보고서(CSR)) 자격을 갖춘 연구자의 요청에 따라 특정 기준, 조건 및 예외가 적용됩니다. 화이자의 데이터 공유 기준 및 액세스 요청 프로세스에 대한 자세한 내용은 https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests에서 확인할 수 있습니다.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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