Eine Studie zu Alisertib in Kombination mit endokriner Therapie bei Patientinnen mit HR-positivem, HER2-negativem rezidivierendem oder metastasiertem Brustkrebs (ALISCA-Breast1)
Eine Phase-2-Studie zu Alisertib in Kombination mit endokriner Therapie bei Patientinnen mit HR+, HER2-negativem rezidivierendem oder metastasiertem Brustkrebs
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
- Name: Puma Biotechnology, Inc. Clinical Operations Senior Director
- Telefonnummer: 424-248-6500
- E-Mail: ClinicalTrials@pumabiotechnology.com
Studienorte
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Lisbon, Portugal, 1998-018
- Rekrutierung
- Hospital CUF Descobertas
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Lisbon, Portugal, 1099-023
- Rekrutierung
- Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)
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Lisbon, Portugal, 1400-038
- Rekrutierung
- Fundação Champalimaud
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Porto, Portugal, 4200-072
- Rekrutierung
- Instituto Português Oncologia Do Porto
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Alicante, Spanien, 03010
- Rekrutierung
- Hospital General Universitario Dr. Balmis
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Barakaldo, Spanien, 48903
- Rekrutierung
- Hospital Universitario de Cruces
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Barcelona, Spanien, 08035
- Rekrutierung
- Hospital Universitario Vall d'Hebron
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Barcelona, Spanien, 08036
- Rekrutierung
- Hospital Clínico de Barcelona
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Bilbao, Spanien, 48013
- Rekrutierung
- Hospital Universitario de Basurto
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Cáceres, Spanien, 10003
- Rekrutierung
- Hospital San Pedro de Alcántara
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Granada, Spanien, 18012
- Rekrutierung
- Hospital San Cecilio
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Huelva, Spanien, 21005
- Rekrutierung
- Hospital Universitario Juan Ramon Jimenez
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Jaén, Spanien, 23007
- Rekrutierung
- Hospital Universitario de Jaén
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Lleida, Spanien, 25198
- Rekrutierung
- Hospital Universitario Arnau de Vilanova
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Madrid, Spanien, 28040
- Rekrutierung
- Hospital Universitario Fundación Jiménez Díaz
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Seville, Spanien, 41013
- Rekrutierung
- Hospital Universitario Virgen del Rocío
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Valencia, Spanien, 46010
- Rekrutierung
- Hospital Clínico Universitario de Valencia
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Valencia, Spanien, 46009
- Rekrutierung
- Fundación Instituto Valenciano de Oncología (IVO)
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Alabama
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Birmingham, Alabama, Vereinigte Staaten, 34235
- Rekrutierung
- Alabama Oncology
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Arizona
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Phoenix, Arizona, Vereinigte Staaten, 85054
- Rekrutierung
- Mayo Clinic Hospital
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California
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Beverly Hills, California, Vereinigte Staaten, 90211
- Rekrutierung
- Beverly Hills Cancer Center
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Fountain Valley, California, Vereinigte Staaten, 92708
- Rekrutierung
- MemorialCare Orange Coast Medical Center
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Irvine, California, Vereinigte Staaten, 92618
- Rekrutierung
- City of Hope at Orange County Lennar Foundation Cancer Center
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Los Angeles, California, Vereinigte Staaten, 90095
- Rekrutierung
- UCLA Department of Medicine - Hematology/Oncology
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Los Angeles, California, Vereinigte Staaten, 90017
- Rekrutierung
- LA Cancer Network
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San Francisco, California, Vereinigte Staaten, 94158
- Rekrutierung
- University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- Rekrutierung
- University of Colorado School of Medicine
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Connecticut
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New Haven, Connecticut, Vereinigte Staaten, 06520
- Zurückgezogen
- Yale University, Yale Cancer Center
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32256
- Rekrutierung
- Cancer Specialists of North Florida
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Jacksonville, Florida, Vereinigte Staaten, 32224
- Rekrutierung
- Mayo Clinic Florida
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Tampa, Florida, Vereinigte Staaten, 33612
- Rekrutierung
- Moffitt Cancer Center
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Georgia
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Atlanta, Georgia, Vereinigte Staaten, 30322
- Rekrutierung
- Winship Cancer Institute, Emory University
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Illinois
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Chicago, Illinois, Vereinigte Staaten, 60612
- Rekrutierung
- University of Illinois Cancer Center
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Chicago, Illinois, Vereinigte Staaten, 60637
- Rekrutierung
- The University of Chicago
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Rekrutierung
- Massachusetts General Hospital
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Boston, Massachusetts, Vereinigte Staaten, 02215
- Rekrutierung
- Dana-Farber Cancer Institute
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Minnesota
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Minneapolis, Minnesota, Vereinigte Staaten, 55455
- Rekrutierung
- University of Minnesota, Masonic Cancer Center
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Rochester, Minnesota, Vereinigte Staaten, 55905
- Rekrutierung
- Mayo Clinic
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Missouri
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Columbia, Missouri, Vereinigte Staaten, 65201
- Rekrutierung
- Missouri Cancer Associates
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Kansas City, Missouri, Vereinigte Staaten, 64111
- Rekrutierung
- Saint Luke's Cancer Institute
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Springfield, Missouri, Vereinigte Staaten, 65807
- Rekrutierung
- Oncology Hematology Associates
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St Louis, Missouri, Vereinigte Staaten, 63110
- Rekrutierung
- Washington University School of Medicine
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Nevada
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Reno, Nevada, Vereinigte Staaten, 89511
- Rekrutierung
- Cancer Care Specialists
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New York
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Rochester, New York, Vereinigte Staaten, 14642
- Rekrutierung
- University of Rochester Medical Center
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27514
- Rekrutierung
- UNC Hospitals, University of North Carolina at Chapel Hill
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Ohio
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Columbus, Ohio, Vereinigte Staaten, 43212
- Rekrutierung
- The Ohio State University, Stefanie Spielman Comprehensive Breast Center
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Maumee, Ohio, Vereinigte Staaten, 43537
- Rekrutierung
- Taylor Cancer Research Center
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Pennsylvania
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Horsham, Pennsylvania, Vereinigte Staaten, 19044
- Rekrutierung
- Alliance Cancer Specialists
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- Rekrutierung
- University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- Rekrutierung
- University of Pittsburgh (UPMC)
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37203
- Rekrutierung
- Tennessee Oncology, Greco-Hainsworth Center for Research
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Texas
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Dallas, Texas, Vereinigte Staaten, 75246
- Rekrutierung
- Texas Oncology
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Virginia
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Richmond, Virginia, Vereinigte Staaten, 23229
- Rekrutierung
- Virginia Cancer Institute
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
Andere Namen:
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 |
|
Experimental: 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.
Andere Namen:
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 |
|
Experimental: 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.
Andere Namen:
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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Objective Response Rate (ORR) Within Dose Subgroup
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
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Percentage of Participants With Treatment-Emergent Adverse Events (Adverse Events and Serious Adverse Events) in the Enrolled Population
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Objective Response Rate (ORR) Within Biomarker-Defined Subgroup
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Chief Reg Affairs, PV, Medical Affairs and Law Officer, Puma Biotechnology, Inc.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PUMA-ALI-1201
- 2024-511497-79-00 (Ctis)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
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-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- CSR
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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