A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alisertib, Endocrine therapy.
- Who it may be relevant to
- Registry conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Portugal, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2 Study of Alisertib in Combination With Endocrine Therapy in Patients With HR+, HER2-negative Recurrent or Metastatic Breast Cancer
Overview
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.
Interventions
- Drug Alisertib
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. - Drug Endocrine therapy
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
Primary outcome measures
- 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]
- Duration of Response (DOR) Within Dose Subgroup [Time frame: From start date of response (after date of randomization) to first PD, assessed up to 48 months]
- Disease Control Rate (DCR) Within Dose Subgroup [Time frame: 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 [Time frame: From date of randomization to date of recurrence, progression or death, assessed up to 48 months]
- Overall Survival (OS) Within Dose Subgroup [Time frame: 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 [Time frame: From date of first dose through last dose plus 28 days, assessed up to 48 months]
Secondary outcome measures (5)
- Objective Response Rate (ORR) Within Biomarker-Defined Subgroup [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: From date of randomization to date of recurrence, progression or death, assessed up to 48 months]
- Overall Survival (OS) Within Biomarker-Defined Subgroup [Time frame: From date of randomization to death, assessed up to 48 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 35 centers
- Alabama Oncology — Birmingham
- Mayo Clinic Hospital — Phoenix
- Beverly Hills Cancer Center — Beverly Hills
- MemorialCare Orange Coast Medical Center — Fountain Valley
- City of Hope at Orange County Lennar Foundation Cancer Center — Irvine
- LA Cancer Network — Los Angeles
- UCLA Department of Medicine - Hematology/Oncology — Los Angeles
- University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Cen — San Francisco
- … and 27 more centers
Spain · 14 centers
- Hospital General Universitario Dr. Balmis — Alicante
- Hospital Universitario de Cruces — Barakaldo
- Hospital Universitario Vall d'Hebron — Barcelona
- Hospital Clínico de Barcelona — Barcelona
- Hospital Universitario de Basurto — Bilbao
- Hospital San Pedro de Alcántara — Cáceres
- Hospital San Cecilio — Granada
- Hospital Universitario Juan Ramon Jimenez — Huelva
- … and 6 more centers
Portugal · 4 centers
- Instituto Português de Oncologia de Lisboa Francisco Gentil (IPO Lisboa) — Lisbon
- Fundação Champalimaud — Lisbon
- Hospital CUF Descobertas — Lisbon
- Instituto Português Oncologia Do Porto — Porto
Identifiers
NCT: NCT06369285 · PUMA-ALI-1201 · 2024-511497-79-00