A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Puma Biotechnology, Inc.
Study ID
NCT06369285
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alisertib — DRUG
    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.
  • Endocrine therapy — DRUG
    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

Study Details

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.

Key Dates

Start date
Nov 19, 2024
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Alisertib 50 mg
    Alisertib with selected endocrine therapy
  • Experimental: Alisertib 40 mg
    Alisertib with selected endocrine therapy
  • Experimental: Alisertib 30 mg
    Alisertib with selected endocrine therapy

Primary Outcome Measure

Objective Response Rate (ORR) Within Dose Subgroup [ Time Frame: From date of randomization to first confirmed Complete or Partial Response, whichever came earlier, assessed up to 48 months ]

Central Contacts

  • Puma Biotechnology, Inc. Clinical Operations Senior Director
    424-248-6500
    [email protected]

Locations (35)

FacilityCityStateZIPSite coordinators
Alabama OncologyBirminghamAlabama34235-
Mayo Clinic HospitalPhoenixArizona85054-
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
MemorialCare Orange Coast Medical CenterFountain ValleyCalifornia92708-
City of Hope at Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618-
LA Cancer NetworkLos AngelesCalifornia90017-
UCLA Department of Medicine - Hematology/OncologyLos AngelesCalifornia90095-
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
University of Colorado School of MedicineAuroraColorado80045-
Yale University, Yale Cancer CenterNew HavenConnecticut06520-
Cancer Specialists of North FloridaJacksonvilleFlorida32256-
Mayo Clinic FloridaJacksonvilleFlorida32224-
Moffitt Cancer CenterTampaFlorida33612-
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
The University of ChicagoChicagoIllinois60637-
University of Illinois Cancer CenterChicagoIllinois60612-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
University of Minnesota, Masonic Cancer CenterMinneapolisMinnesota55455-
Mayo ClinicRochesterMinnesota55905-
Missouri Cancer AssociatesColumbiaMissouri65201-
Saint Luke's Cancer InstituteKansas CityMissouri64111-
Oncology Hematology AssociatesSpringfieldMissouri65807-
Washington University School of MedicineSt LouisMissouri63110-
Cancer Care SpecialistsRenoNevada89511-
University of Rochester Medical CenterRochesterNew York14642-
UNC Hospitals, University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
The Ohio State University, Stefanie Spielman Comprehensive Breast CenterColumbusOhio43212-
Taylor Cancer Research CenterMaumeeOhio43537-
Alliance Cancer SpecialistsHorshamPennsylvania19044-
University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104-
University of Pittsburgh (UPMC)PittsburghPennsylvania15213-
Tennessee Oncology, Greco-Hainsworth Center for ResearchNashvilleTennessee37203-
Texas OncologyDallasTexas75246-
Virginia Cancer InstituteRichmondVirginia23229-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Alabama Oncology· Birmingham, ALMayo Clinic Hospital· Phoenix, AZBeverly Hills Cancer Center· Beverly Hills, CAMemorialCare Orange Coast Medical Center· Fountain Valley, CACity of Hope at Orange County Lennar Foundation Cancer Center· Irvine, CALA Cancer Network· Los Angeles, CA

Related Studies