En undersøgelse af Alisertib i kombination med endokrin terapi hos patienter med HR-positiv, HER2-negativ tilbagevendende eller metastatisk brystkræft (ALISCA-Breast1)
Et fase 2-studie af Alisertib i kombination med endokrin terapi hos patienter med HR+, HER2-negativ tilbagevendende eller metastatisk brystkræft
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Puma Biotechnology, Inc. Clinical Operations Senior Director
- Telefonnummer: 424-248-6500
- E-mail: ClinicalTrials@pumabiotechnology.com
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 34235
- Rekruttering
- Alabama Oncology
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Arizona
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Phoenix, Arizona, Forenede Stater, 85054
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- Mayo Clinic Hospital
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California
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Beverly Hills, California, Forenede Stater, 90211
- Rekruttering
- Beverly Hills Cancer Center
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Fountain Valley, California, Forenede Stater, 92708
- Rekruttering
- MemorialCare Orange Coast Medical Center
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Irvine, California, Forenede Stater, 92618
- Rekruttering
- City of Hope at Orange County Lennar Foundation Cancer Center
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Los Angeles, California, Forenede Stater, 90095
- Rekruttering
- UCLA Department of Medicine - Hematology/Oncology
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Los Angeles, California, Forenede Stater, 90017
- Rekruttering
- LA Cancer Network
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San Francisco, California, Forenede Stater, 94158
- Rekruttering
- University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Rekruttering
- University of Colorado School of Medicine
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06520
- Trukket tilbage
- Yale University, Yale Cancer Center
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Florida
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Jacksonville, Florida, Forenede Stater, 32256
- Rekruttering
- Cancer Specialists of North Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Mayo Clinic Florida
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Tampa, Florida, Forenede Stater, 33612
- Rekruttering
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Rekruttering
- Winship Cancer Institute, Emory University
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Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Rekruttering
- University of Illinois Cancer Center
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Chicago, Illinois, Forenede Stater, 60637
- Rekruttering
- The University of Chicago
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Rekruttering
- Massachusetts General Hospital
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Boston, Massachusetts, Forenede Stater, 02215
- Rekruttering
- Dana-Farber Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
- Rekruttering
- University of Minnesota, Masonic Cancer Center
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Rochester, Minnesota, Forenede Stater, 55905
- Rekruttering
- Mayo Clinic
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Missouri
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Columbia, Missouri, Forenede Stater, 65201
- Rekruttering
- Missouri Cancer Associates
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Kansas City, Missouri, Forenede Stater, 64111
- Rekruttering
- Saint Luke's Cancer Institute
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Springfield, Missouri, Forenede Stater, 65807
- Rekruttering
- Oncology Hematology Associates
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St Louis, Missouri, Forenede Stater, 63110
- Rekruttering
- Washington University School of Medicine
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Nevada
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Reno, Nevada, Forenede Stater, 89511
- Rekruttering
- Cancer Care Specialists
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New York
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Rochester, New York, Forenede Stater, 14642
- Rekruttering
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514
- Rekruttering
- UNC Hospitals, University of North Carolina at Chapel Hill
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Ohio
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Columbus, Ohio, Forenede Stater, 43212
- Rekruttering
- The Ohio State University, Stefanie Spielman Comprehensive Breast Center
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Maumee, Ohio, Forenede Stater, 43537
- Rekruttering
- Taylor Cancer Research Center
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Pennsylvania
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Horsham, Pennsylvania, Forenede Stater, 19044
- Rekruttering
- Alliance Cancer Specialists
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Rekruttering
- University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Rekruttering
- University of Pittsburgh (UPMC)
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37203
- Rekruttering
- Tennessee Oncology, Greco-Hainsworth Center for Research
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Texas
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Dallas, Texas, Forenede Stater, 75246
- Rekruttering
- Texas Oncology
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Virginia
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Richmond, Virginia, Forenede Stater, 23229
- Rekruttering
- Virginia Cancer Institute
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Lisbon, Portugal, 1998-018
- Rekruttering
- Hospital CUF Descobertas
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Lisbon, Portugal, 1099-023
- Rekruttering
- Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)
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Lisbon, Portugal, 1400-038
- Rekruttering
- Fundação Champalimaud
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Porto, Portugal, 4200-072
- Rekruttering
- Instituto Português Oncologia Do Porto
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Alicante, Spanien, 03010
- Rekruttering
- Hospital General Universitario Dr. Balmis
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Barakaldo, Spanien, 48903
- Rekruttering
- Hospital Universitario de Cruces
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Barcelona, Spanien, 08035
- Rekruttering
- Hospital Universitario Vall d'Hebron
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Barcelona, Spanien, 08036
- Rekruttering
- Hospital Clínico de Barcelona
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Bilbao, Spanien, 48013
- Rekruttering
- Hospital Universitario de Basurto
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Cáceres, Spanien, 10003
- Rekruttering
- Hospital San Pedro de Alcántara
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Granada, Spanien, 18012
- Rekruttering
- Hospital San Cecilio
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Huelva, Spanien, 21005
- Rekruttering
- Hospital Universitario Juan Ramon Jimenez
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Jaén, Spanien, 23007
- Rekruttering
- Hospital Universitario de Jaén
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Lleida, Spanien, 25198
- Rekruttering
- Hospital Universitario Arnau de Vilanova
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Madrid, Spanien, 28040
- Rekruttering
- Hospital Universitario Fundación Jiménez Díaz
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Seville, Spanien, 41013
- Rekruttering
- Hospital Universitario Virgen del Rocío
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Valencia, Spanien, 46010
- Rekruttering
- Hospital Clínico Universitario de Valencia
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Valencia, Spanien, 46009
- Rekruttering
- Fundación Instituto Valenciano de Oncología (IVO)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Alisertib 50 mg
Alisertib with selected endocrine therapy |
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.
Andre navne:
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 |
|
Eksperimentel: Alisertib 40 mg
Alisertib with selected endocrine therapy |
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.
Andre navne:
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 |
|
Eksperimentel: Alisertib 30 mg
Alisertib with selected endocrine therapy Cohort closed to enrollment in Amendment 4 |
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.
Andre navne:
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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Objective Response Rate (ORR) Within Dose Subgroup
Tidsramme: 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
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Duration of Response (DOR) Within Dose Subgroup
Tidsramme: 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
|
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Disease Control Rate (DCR) Within Dose Subgroup
Tidsramme: 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
|
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Progression Free Survival (PFS) Within Dose Subgroup
Tidsramme: 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
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Overall Survival (OS) Within Dose Subgroup
Tidsramme: From date of randomization to death, assessed up to 48 months
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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
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Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population
Tidsramme: From date of first dose through last dose plus 28 days, assessed up to 48 months
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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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response Rate (ORR) Within Biomarker-Defined Subgroup
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Chief Reg Affairs, PV, Medical Affairs and Law Officer, Puma Biotechnology, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PUMA-ALI-1201
- 2024-511497-79-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
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-delingsadgangskriterier
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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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