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

Recruiting Phase 2 Interventional Study
Hormone Receptor Positive HER-2 Negative Breast Cancer Metastatic Breast Cancer Recurrent Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
225 (estimated)
Sponsor
Puma Biotechnology, Inc. · Industry
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About This Trial
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 op…
Trial Locations
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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 recu…
Contacts

Puma Biotechnology, Inc. Clinical Operations Senior Director

424-248-6500

ClinicalTrials@pumabiotechnology.com

CONTACT