Status and phase
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Treatments
About
This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Histologically-proven, ER-positive, HER2-negative locally advanced, inoperable, and/or metastatic breast cancer.
Female patients with menopausal status:
i. Postmenopausal status defined as meeting at least one of the following criteria:
ii. Premenopausal or perimenopausal concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 4 weeks before the start of trial therapy and is planned to continue LHRH agonist during the study.
Patients meeting all the following criteria:
Exclusion criteria
Patients with prior anticancer or investigational drug treatment within the following windows are excluded:
Participants with prior anticancer or investigational drug treatment within the following windows are excluded:
Patients with untreated or symptomatic or progressive central nervous system (CNS) metastases.
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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