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Trial Title:
A Study of Alisertib in Combination with Endocrine Therapy in Patients with HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
NCT ID:
NCT06369285
Condition:
Hormone Receptor Positive HER-2 Negative Breast Cancer
Metastatic Breast Cancer
Recurrent Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Recurrence
Conditions: Keywords:
Hormone receptor positive (HR+)
Human epidermal growth factor receptor 2 negative (HER2-)
Recurrent Breast Cancer
Metastatic Breast Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Alisertib
Description:
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.
Arm group label:
Alisertib 30 mg
Arm group label:
Alisertib 40 mg
Arm group label:
Alisertib 50 mg
Other name:
PB-8237
Other name:
MLN8237
Intervention type:
Drug
Intervention name:
Endocrine therapy
Description:
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
Arm group label:
Alisertib 30 mg
Arm group label:
Alisertib 40 mg
Arm group label:
Alisertib 50 mg
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Aged ≥18 years at signing of informed consent.
- Pathology-confirmed diagnosis of adenocarcinoma of the breast 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.
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale University, Yale Cancer Center
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Facility:
Name:
Taylor Cancer Research Center
Address:
City:
Maumee
Zip:
43537
Country:
United States
Status:
Recruiting
Start date:
December 31, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Puma Biotechnology, Inc.
Agency class:
Industry
Source:
Puma Biotechnology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06369285
