이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

HR 양성, HER2 음성 재발성 또는 전이성 유방암 환자를 대상으로 알리세르팁과 내분비 요법을 병용한 연구 (ALISCA-Breast1)

2026년 9월 28일 업데이트: Puma Biotechnology, Inc.

HR+, HER2 음성 재발성 또는 전이성 유방암 환자를 대상으로 알리세르팁과 내분비 요법을 병용한 2상 연구

PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines of endocrine therapy in the recurrent or metastatic setting. This study is intended to evaluate the optimal alisertib dose administered in combination with the selected endocrine therapy. The study is also planned to evaluate the efficacy, safety, and pharmacokinetics of alisertib in combination with endocrine and to identify the biomarker-defined subgroup(s) that may benefit most from combined alisertib and endocrine therapy. Participants randomized prior to Amendment 4 are randomized 1:1:1 to Arm 1, Arm 2 or Arm 3. Participants randomized under Amendment 4 will be randomized 1:1 to Arm 1 or Arm 2.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

225

단계

  • 2 단계

연락처 및 위치

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

연구 연락처

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 34235
        • 모병
        • Alabama Oncology
    • Arizona
      • Phoenix, Arizona, 미국, 85054
        • 모병
        • Mayo Clinic Hospital
    • California
      • Beverly Hills, California, 미국, 90211
        • 모병
        • Beverly Hills Cancer Center
      • Fountain Valley, California, 미국, 92708
        • 모병
        • MemorialCare Orange Coast Medical Center
      • Irvine, California, 미국, 92618
        • 모병
        • City of Hope at Orange County Lennar Foundation Cancer Center
      • Los Angeles, California, 미국, 90095
        • 모병
        • UCLA Department of Medicine - Hematology/Oncology
      • Los Angeles, California, 미국, 90017
        • 모병
        • LA Cancer Network
      • San Francisco, California, 미국, 94158
        • 모병
        • University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • 모병
        • University of Colorado School of Medicine
    • Connecticut
      • New Haven, Connecticut, 미국, 06520
        • 빼는
        • Yale University, Yale Cancer Center
    • Florida
      • Jacksonville, Florida, 미국, 32256
        • 모병
        • Cancer Specialists of North Florida
      • Jacksonville, Florida, 미국, 32224
        • 모병
        • Mayo Clinic Florida
      • Tampa, Florida, 미국, 33612
        • 모병
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • 모병
        • Winship Cancer Institute, Emory University
    • Illinois
      • Chicago, Illinois, 미국, 60612
        • 모병
        • University of Illinois Cancer Center
      • Chicago, Illinois, 미국, 60637
        • 모병
        • The University of Chicago
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital
      • Boston, Massachusetts, 미국, 02215
        • 모병
        • Dana-Farber Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55455
        • 모병
        • University of Minnesota, Masonic Cancer Center
      • Rochester, Minnesota, 미국, 55905
        • 모병
        • Mayo Clinic
    • Missouri
      • Columbia, Missouri, 미국, 65201
        • 모병
        • Missouri Cancer Associates
      • Kansas City, Missouri, 미국, 64111
        • 모병
        • Saint Luke's Cancer Institute
      • Springfield, Missouri, 미국, 65807
        • 모병
        • Oncology Hematology Associates
      • St Louis, Missouri, 미국, 63110
        • 모병
        • Washington University School of Medicine
    • Nevada
      • Reno, Nevada, 미국, 89511
        • 모병
        • Cancer Care Specialists
    • New York
      • Rochester, New York, 미국, 14642
        • 모병
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27514
        • 모병
        • UNC Hospitals, University of North Carolina at Chapel Hill
    • Ohio
      • Columbus, Ohio, 미국, 43212
        • 모병
        • The Ohio State University, Stefanie Spielman Comprehensive Breast Center
      • Maumee, Ohio, 미국, 43537
        • 모병
        • Taylor Cancer Research Center
    • Pennsylvania
      • Horsham, Pennsylvania, 미국, 19044
        • 모병
        • Alliance Cancer Specialists
      • Philadelphia, Pennsylvania, 미국, 19104
        • 모병
        • University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine
      • Pittsburgh, Pennsylvania, 미국, 15213
        • 모병
        • University of Pittsburgh (UPMC)
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • 모병
        • Tennessee Oncology, Greco-Hainsworth Center for Research
    • Texas
      • Dallas, Texas, 미국, 75246
        • 모병
        • Texas Oncology
    • Virginia
      • Richmond, Virginia, 미국, 23229
        • 모병
        • Virginia Cancer Institute
  • 스페인
      • Alicante, 스페인, 03010
        • 모병
        • Hospital General Universitario Dr. Balmis
      • Barakaldo, 스페인, 48903
        • 모병
        • Hospital Universitario de Cruces
      • Barcelona, 스페인, 08035
        • 모병
        • Hospital Universitario Vall d'Hebron
      • Barcelona, 스페인, 08036
        • 모병
        • Hospital Clínico de Barcelona
      • Bilbao, 스페인, 48013
        • 모병
        • Hospital Universitario de Basurto
      • Cáceres, 스페인, 10003
        • 모병
        • Hospital San Pedro de Alcántara
      • Granada, 스페인, 18012
        • 모병
        • Hospital San Cecilio
      • Huelva, 스페인, 21005
        • 모병
        • Hospital Universitario Juan Ramon Jimenez
      • Jaén, 스페인, 23007
        • 모병
        • Hospital Universitario de Jaén
      • Lleida, 스페인, 25198
        • 모병
        • Hospital Universitario Arnau de Vilanova
      • Madrid, 스페인, 28040
        • 모병
        • Hospital Universitario Fundación Jiménez Díaz
      • Seville, 스페인, 41013
        • 모병
        • Hospital Universitario Virgen del Rocío
      • Valencia, 스페인, 46010
        • 모병
        • Hospital Clínico Universitario de Valencia
      • Valencia, 스페인, 46009
        • 모병
        • Fundación Instituto Valenciano de Oncología (IVO)
  • 포르투갈
      • Lisbon, 포르투갈, 1998-018
        • 모병
        • Hospital CUF Descobertas
      • Lisbon, 포르투갈, 1099-023
        • 모병
        • Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)
      • Lisbon, 포르투갈, 1400-038
        • 모병
        • Fundação Champalimaud
      • Porto, 포르투갈, 4200-072
        • 모병
        • Instituto Português Oncologia Do Porto

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Aged ≥18 years at signing of informed consent.
  • Pathology-confirmed diagnosis of breast cancer with evidence of recurrent or metastatic disease not amenable to curative therapy.
  • Progression on or after treatment with at least two prior lines of endocrine therapy in the recurrent or metastatic setting. a. If metastatic disease recurrence occurs during or within six months of discontinuing adjuvant endocrine therapy, then that endocrine therapy will count as one line of prior therapy.
  • Participants must have received a CDK4/6i in combination with endocrine therapy in the recurrent or metastatic setting.
  • HR-positive and HER2-negative tumor status reported per local laboratory testing. HR and HER2 testing must be performed consistent with current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) or European Society of Medical Oncology (ESMO) guidelines.

Exclusion Criteria:

  • Treatment with chemotherapy in the recurrent or metastatic setting, including antibody drug conjugates with a chemotherapeutic payload.
  • Prior treatment with an Aurora Kinase A (AURKA) specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.

Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Alisertib 50 mg

Alisertib with selected endocrine therapy
의약품: Alisertib

Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.

다른 이름들:
  • MLN8237
  • PB-8237
의약품: Endocrine therapy

Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information.

1 mg of anastrozole tablet by mouth once daily or

2.5 mg of letrozole tablet by mouth once daily or

25 mg of exemestane tablet by mouth once daily or

20 mg of tamoxifen tablet by mouth once daily or

500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter
실험적: Alisertib 40 mg

Alisertib with selected endocrine therapy
의약품: Alisertib

Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.

다른 이름들:
  • MLN8237
  • PB-8237
의약품: Endocrine therapy

Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information.

1 mg of anastrozole tablet by mouth once daily or

2.5 mg of letrozole tablet by mouth once daily or

25 mg of exemestane tablet by mouth once daily or

20 mg of tamoxifen tablet by mouth once daily or

500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter
실험적: Alisertib 30 mg

Alisertib with selected endocrine therapy

Cohort closed to enrollment in Amendment 4
의약품: Alisertib

Alisertib enteric-coated tablets will be taken by mouth twice daily on days 1-3, 8-10, and 15-17 of each 28-day cycle.

다른 이름들:
  • MLN8237
  • PB-8237
의약품: Endocrine therapy

Investigator selected endocrine therapy will be taken in 28-day dosing cycles according to the approved prescribing information.

1 mg of anastrozole tablet by mouth once daily or

2.5 mg of letrozole tablet by mouth once daily or

25 mg of exemestane tablet by mouth once daily or

20 mg of tamoxifen tablet by mouth once daily or

500 mg of fulvestrant intramuscular injection on Study Day 1, 15, 29, and once every 28 days thereafter

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate (ORR) Within Dose Subgroup
기간: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months

Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
Duration of Response (DOR) Within Dose Subgroup
기간: From start date of response (after date of randomization) to first PD, assessed up to 48 months

Duration of response is measured from the time at which measurement criteria are first met for Complete Response (CR) or Partial Response (PR) (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.
From start date of response (after date of randomization) to first PD, assessed up to 48 months
Disease Control Rate (DCR) Within Dose Subgroup
기간: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months

Disease control rate is the proportion of participants who achieve overall tumor response (confirmed CR or PR) or Stable Disease (SD) lasting for at least 24 weeks from randomization.
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
Progression Free Survival (PFS) Within Dose Subgroup
기간: From date of randomization to date of recurrence, progression or death, assessed up to 48 months

Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of randomization until the first date on which recurrence, progression, or death due to any cause, is documented.
From date of randomization to date of recurrence, progression or death, assessed up to 48 months
Overall Survival (OS) Within Dose Subgroup
기간: From date of randomization to death, assessed up to 48 months

Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier.
From date of randomization to death, assessed up to 48 months
Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population
기간: From date of first dose through last dose plus 28 days, assessed up to 48 months

Treatment emergent adverse events are those events reported on or after the first dose of investigational product and up to 28 days after last dose.
From date of first dose through last dose plus 28 days, assessed up to 48 months

2차 결과 측정

결과 측정
측정값 설명
기간
Objective Response Rate (ORR) Within Biomarker-Defined Subgroup
기간: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months

Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
Duration of Response (DOR) Within Biomarker-Defined Subgroup
기간: From start date of response (after date of randomization) to first PD, assessed up to 48 months

Duration of response is measured from the time at which measurement criteria are first met for CR or PR (whichever status is recorded first) until the first date of recurrence or progressive disease (PD) or death is objectively documented.
From start date of response (after date of randomization) to first PD, assessed up to 48 months
Disease Control Rate (DCR) Within Biomarker-Defined Subgroup
기간: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months

Disease control rate is the proportion of participants who achieve overall tumor response (confirmed CR or PR) or SD lasting for at least 24 weeks from randomization.
From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months
Progression Free Survival (PFS) Within Biomarker-Defined Subgroup
기간: From date of randomization to date of recurrence, progression or death, assessed up to 48 months

Progression Free Survival (PFS) is measured in months and based on the local tumor assessment. The time interval from the date of randomization until the first date on which recurrence, progression, or death due to any cause, is documented.
From date of randomization to date of recurrence, progression or death, assessed up to 48 months
Overall Survival (OS) Within Biomarker-Defined Subgroup
기간: From date of randomization to death, assessed up to 48 months

Overall survival (OS) is defined as the time from randomization to death due to any cause, censored at the last date known alive on or prior to the data cutoff employed for the analysis, whichever was earlier.
From date of randomization to death, assessed up to 48 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Puma Biotechnology, Inc.

수사관

  • 연구 책임자: Chief Reg Affairs, PV, Medical Affairs and Law Officer, Puma Biotechnology, Inc.

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)

2024년 11월 19일

기본 완료 (추정된)

2027년 12월 30일

연구 완료 (추정된)

2029년 6월 30일

연구 등록 날짜

최초 제출

2024년 4월 12일

QC 기준을 충족하는 최초 제출

2024년 4월 12일

처음 게시됨 (실제)

2024년 4월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 28일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PUMA-ALI-1201
  • 2024-511497-79-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

IPD 공유 기간

Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.

IPD 공유 액세스 기준

Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.

Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

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. .

구독하다