Tests alisertib with endocrine therapy in hormone-positive, HER2-negative advanced breast cancer
Tests alisertib plus endocrine therapy in adults with advanced hormone-positive breast cancer.
Key facts
- Who runs it
- Puma Biotechnology, Inc.
- Where
- Lisbon and Porto, PortugalSee the 4 sitesAlso in 2 other countries, 49 sites
- Trial code
- Registry title
- A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 225 people, planned
- Started
- 19 Nov 2024
- Expected to end
- 30 Jun 2029
- Type of study
- Interventional, 3 groups
- Treatments tested
- Alisertib
- Endocrine therapy
- Record updated
- 1 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with breast cancer that has come back or spread, and is HR-positive and HER2-negative. Their cancer must have grown after at least two earlier hormone treatments.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Breast cancer confirmed by pathology that has come back or spread (metastatic) and cannot be cured by treatment. Tumor must be HR-positive and HER2-negative.
- Earlier treatment
- Must have had at least two earlier lines of endocrine (hormone) therapy for recurrent or metastatic disease, and must have had a CDK4/6 inhibitor together with endocrine therapy. Must not have had chemotherapy for recurrent or metastatic disease, or any Aurora Kinase A-targeted drug, including alisertib.
- Biomarker or test result
- HR-positive and HER2-negative tumor, shown by local laboratory testing that follows ASCO/CAP or ESMO guidelines.
Main reasons for not taking part
- Chemotherapy for recurrent or metastatic disease, including antibody drug conjugates with a chemotherapy payload
- Earlier treatment with an Aurora Kinase A-targeted or pan-Aurora-targeted drug, including alisertib
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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 take part
- 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
Where in Portugal
Also in 2 other countries, 49 sites
- Champalimaud Clinical CentreLisbon, PortugalTaking people
- Hospital Cuf Descobertas S.A.Lisbon, PortugalTaking people
- Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.Lisbon, PortugalTaking people
- Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.Porto, PortugalTaking people
About the trial
What the trial wants to find out
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.
The 3 groups in the trial
- Alisertib 50 mgTreatment being tested
Alisertib with selected endocrine therapy
Treatment: Alisertib and Endocrine therapy
- Alisertib 40 mgTreatment being tested
Alisertib with selected endocrine therapy
Treatment: Alisertib and Endocrine therapy
- Alisertib 30 mgTreatment being tested
Alisertib with selected endocrine therapy Cohort closed to enrollment in Amendment 4
Treatment: Alisertib and Endocrine therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer
- Plain-language title
- Tests alisertib with endocrine therapy in hormone-positive, HER2-negative advanced breast cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 1 October 2026