Hormone Receptor Positive HER-2 Negative Breast CancerPhase 2ALISCA-Breast1NCT06369285
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
A Phase 2 study testing Alisertib and Endocrine therapy in people with Hormone Receptor Positive HER-2 Negative Breast Cancer and Metastatic Breast Cancer, run by Puma Biotechnology, Inc. at 53 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- What is being tested?
- Alisertib and Endocrine therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 53 sitesin 3 countries
- Study dates
- 19 Nov 2024to 30 Jun 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
53 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Puma Biotechnology, Inc. Clinical Operations Senior Director contact
53 sites in 3 countries
United States35 sites, 34 recruiting
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
- Recruiting
University of Colorado School of Medicine
Aurora, Colorado, 80045
- Recruiting
Beverly Hills Cancer Center
Beverly Hills, California, 90211
- Recruiting
Alabama Oncology
Birmingham, Alabama, 34235
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
UNC Hospitals, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
- Recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
- Recruiting
Missouri Cancer Associates
Columbia, Missouri, 65201
- Recruiting
The Ohio State University, Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212
- Recruiting
Texas Oncology
Dallas, Texas, 75246
- Recruiting
MemorialCare Orange Coast Medical Center
Fountain Valley, California, 92708
- Recruiting
Alliance Cancer Specialists
Horsham, Pennsylvania, 19044
- Recruiting
City of Hope at Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
- Recruiting
Cancer Specialists of North Florida
Jacksonville, Florida, 32256
- Recruiting
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111
- Recruiting
LA Cancer Network
Los Angeles, California, 90017
- Recruiting
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
- Recruiting
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, 55455
- Recruiting
Tennessee Oncology, Greco-Hainsworth Center for Research
Nashville, Tennessee, 37203
- Withdrawn
Yale University, Yale Cancer Center
New Haven, Connecticut, 06520
- Recruiting
University of Pennsylvania, Abramson Cancer Center, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
- Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
- Recruiting
University of Pittsburgh (UPMC)
Pittsburgh, Pennsylvania, 15213
- Recruiting
Cancer Care Specialists
Reno, Nevada, 89511
- Recruiting
Virginia Cancer Institute
Richmond, Virginia, 23229
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
- Recruiting
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
- Recruiting
Oncology Hematology Associates
Springfield, Missouri, 65807
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Spain14 sites, 14 recruiting
- Recruiting
Hospital General Universitario Dr. Balmis
Alicante, 03010
- Recruiting
Hospital Universitario de Cruces
Barakaldo, 48903
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Clínico de Barcelona
Barcelona, 08036
- Recruiting
Hospital Universitario de Basurto
Bilbao, 48013
- Recruiting
Hospital San Pedro de Alcántara
Cáceres, 10003
- Recruiting
Hospital San Cecilio
Granada, 18012
- Recruiting
Hospital Universitario Juan Ramon Jimenez
Huelva, 21005
- Recruiting
Hospital Universitario de Jaén
Jaén, 23007
- Recruiting
Hospital Universitario Arnau de Vilanova
Lleida, 25198
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, 41013
- Recruiting
Fundación Instituto Valenciano de Oncología (IVO)
Valencia, 46009
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
Portugal4 sites, 4 recruiting
- Recruiting
Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa)
Lisbon, 1099-023
- Recruiting
Fundação Champalimaud
Lisbon, 1400-038
- Recruiting
Hospital CUF Descobertas
Lisbon, 1998-018
- Recruiting
Instituto Português Oncologia Do Porto
Porto, 4200-072
About this study
Official title: A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer
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.
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Being tested
- Alisertib, Endocrine therapy
- Keywords
- Hormone receptor positive (HR+), Human epidermal growth factor receptor 2 negative (HER2-), Recurrent Breast Cancer, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlisertibDrug
Also called PB-8237, MLN8237
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 therapyDrug
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 group | Role | What they receive |
|---|---|---|
| Alisertib 50 mg | Experimental | Alisertib with selected endocrine therapy Receives: Drug: Alisertib; Drug: Endocrine therapy |
| Alisertib 40 mg | Experimental | Alisertib with selected endocrine therapy Receives: Drug: Alisertib; Drug: Endocrine therapy |
| Alisertib 30 mg | Experimental | Alisertib with selected endocrine therapy
Cohort closed to enrollment in Amendment 4 Receives: Drug: Alisertib; Drug: Endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) Within Dose Subgroup
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.
Measured: 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
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.
Measured: From start date of response (after date of randomization) to first PD, assessed up to 48 months
Disease Control Rate (DCR) Within Dose Subgroup
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.
Measured: 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
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.
Measured: From date of randomization to date of recurrence, progression or death, assessed up to 48 months
Overall Survival (OS) Within Dose Subgroup
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.
Measured: 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
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.
Measured: From date of first dose through last dose plus 28 days, assessed up to 48 months
Secondary outcomes (5)
Objective Response Rate (ORR) Within Biomarker-Defined Subgroup
Objective response rate is defined as the percentage of participants demonstrating a confirmed objective response during the study.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: From date of randomization to date of recurrence, progression or death, assessed up to 48 months
Overall Survival (OS) Within Biomarker-Defined Subgroup
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.
Measured: From date of randomization to death, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start19 Nov 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Receptor Positive HER-2 Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puma Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Reg Affairs, PV, Medical Affairs and Law Officer, Study director, Puma Biotechnology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369285
- Sponsor's protocol ID
- PUMA-ALI-1201
- Other IDs
- 2024-511497-79-00
- Acronym
- ALISCA-Breast1
- Status last verified
- Sep 2026
- First submitted
- 12 Apr 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.