En studie av Alisertib i kombination med endokrin terapi hos patienter med HR-positiv, HER2-negativ återkommande eller metastaserad bröstcancer (ALISCA-Breast1)
En fas 2-studie av Alisertib i kombination med endokrin terapi hos patienter med HR+, HER2-negativ återkommande eller metastaserad bröstcancer
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Puma Biotechnology, Inc. Clinical Operations Senior Director
- Telefonnummer: 424-248-6500
- E-post: ClinicalTrials@pumabiotechnology.com
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 34235
- Rekrytering
- Alabama Oncology
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Arizona
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Phoenix, Arizona, Förenta staterna, 85054
- Rekrytering
- Mayo Clinic Hospital
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California
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Beverly Hills, California, Förenta staterna, 90211
- Rekrytering
- Beverly Hills Cancer Center
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Fountain Valley, California, Förenta staterna, 92708
- Rekrytering
- MemorialCare Orange Coast Medical Center
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Irvine, California, Förenta staterna, 92618
- Rekrytering
- City of Hope at Orange County Lennar Foundation Cancer Center
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Los Angeles, California, Förenta staterna, 90095
- Rekrytering
- UCLA Department of Medicine - Hematology/Oncology
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Los Angeles, California, Förenta staterna, 90017
- Rekrytering
- LA Cancer Network
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San Francisco, California, Förenta staterna, 94158
- Rekrytering
- University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- Rekrytering
- University of Colorado School of Medicine
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Connecticut
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New Haven, Connecticut, Förenta staterna, 06520
- Indragen
- Yale University, Yale Cancer Center
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Florida
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Jacksonville, Florida, Förenta staterna, 32256
- Rekrytering
- Cancer Specialists of North Florida
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Jacksonville, Florida, Förenta staterna, 32224
- Rekrytering
- Mayo Clinic Florida
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Tampa, Florida, Förenta staterna, 33612
- Rekrytering
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Rekrytering
- Winship Cancer Institute, Emory University
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Rekrytering
- University of Illinois Cancer Center
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Chicago, Illinois, Förenta staterna, 60637
- Rekrytering
- The University of Chicago
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Rekrytering
- Massachusetts General Hospital
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Boston, Massachusetts, Förenta staterna, 02215
- Rekrytering
- Dana-Farber Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55455
- Rekrytering
- University of Minnesota, Masonic Cancer Center
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Rochester, Minnesota, Förenta staterna, 55905
- Rekrytering
- Mayo Clinic
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Missouri
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Columbia, Missouri, Förenta staterna, 65201
- Rekrytering
- Missouri Cancer Associates
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Kansas City, Missouri, Förenta staterna, 64111
- Rekrytering
- Saint Luke's Cancer Institute
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Springfield, Missouri, Förenta staterna, 65807
- Rekrytering
- Oncology Hematology Associates
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St Louis, Missouri, Förenta staterna, 63110
- Rekrytering
- Washington University School of Medicine
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Nevada
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Reno, Nevada, Förenta staterna, 89511
- Rekrytering
- Cancer Care Specialists
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New York
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Rochester, New York, Förenta staterna, 14642
- Rekrytering
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Förenta staterna, 27514
- Rekrytering
- UNC Hospitals, University of North Carolina at Chapel Hill
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Ohio
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Columbus, Ohio, Förenta staterna, 43212
- Rekrytering
- The Ohio State University, Stefanie Spielman Comprehensive Breast Center
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Maumee, Ohio, Förenta staterna, 43537
- Rekrytering
- Taylor Cancer Research Center
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Pennsylvania
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Horsham, Pennsylvania, Förenta staterna, 19044
- Rekrytering
- Alliance Cancer Specialists
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Rekrytering
- University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- Rekrytering
- University of Pittsburgh (UPMC)
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37203
- Rekrytering
- Tennessee Oncology, Greco-Hainsworth Center for Research
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Texas
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Dallas, Texas, Förenta staterna, 75246
- Rekrytering
- Texas Oncology
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Virginia
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Richmond, Virginia, Förenta staterna, 23229
- Rekrytering
- Virginia Cancer Institute
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Lisbon, Portugal, 1998-018
- Rekrytering
- Hospital CUF Descobertas
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Lisbon, Portugal, 1099-023
- Rekrytering
- Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)
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Lisbon, Portugal, 1400-038
- Rekrytering
- Fundação Champalimaud
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Porto, Portugal, 4200-072
- Rekrytering
- Instituto Português Oncologia Do Porto
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Alicante, Spanien, 03010
- Rekrytering
- Hospital General Universitario Dr. Balmis
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Barakaldo, Spanien, 48903
- Rekrytering
- Hospital Universitario de Cruces
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Barcelona, Spanien, 08035
- Rekrytering
- Hospital Universitario Vall d'Hebron
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Barcelona, Spanien, 08036
- Rekrytering
- Hospital Clínico de Barcelona
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Bilbao, Spanien, 48013
- Rekrytering
- Hospital Universitario de Basurto
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Cáceres, Spanien, 10003
- Rekrytering
- Hospital San Pedro de Alcántara
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Granada, Spanien, 18012
- Rekrytering
- Hospital San Cecilio
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Huelva, Spanien, 21005
- Rekrytering
- Hospital Universitario Juan Ramon Jimenez
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Jaén, Spanien, 23007
- Rekrytering
- Hospital Universitario de Jaén
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Lleida, Spanien, 25198
- Rekrytering
- Hospital Universitario Arnau de Vilanova
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Madrid, Spanien, 28040
- Rekrytering
- Hospital Universitario Fundación Jiménez Díaz
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Seville, Spanien, 41013
- Rekrytering
- Hospital Universitario Virgen del Rocío
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Valencia, Spanien, 46010
- Rekrytering
- Hospital Clínico Universitario de Valencia
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Valencia, Spanien, 46009
- Rekrytering
- Fundación Instituto Valenciano de Oncología (IVO)
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
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 |
|
Experimentell: 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.
Andra namn:
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 |
|
Experimentell: 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.
Andra namn:
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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Objective Response Rate (ORR) Within Dose Subgroup
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Objective Response Rate (ORR) Within Biomarker-Defined Subgroup
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Chief Reg Affairs, PV, Medical Affairs and Law Officer, Puma Biotechnology, Inc.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PUMA-ALI-1201
- 2024-511497-79-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- CSR
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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