OASIS Breast Cancer Trial
Phase II Trial of OrAl SM-88 in Patients With
Metastatic Hormone Receptor-posItive
HER2-negative (HR+/HER2-) breaSt Cancer
About OASIS Breast Cancer Trial
This is a phase Il single arm, open -label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer. It is designed to determine efficacy, defined as the objective response rate (ORR) of this investigational treatment. It is hypothesized that SM-88 used with MPS will lead to encouraging
anti-tumor responses with acceptable toxicities in patients with metastatic HR+/HER2- breast cancer.
This is a multicenter phase Il single arm trial designed to evaluate the efficacy of SM-88 plus three subtherapeutic conditioning agents (methoxsalen, phenytoin, and sirolimus [MPS]) in patients with metastatic HR+/HER2- breast cancer. Thirty patients will be enrolled in first stage of the study, and if 3 or more patients have an objective response (complete or partial response) then an additional 20 patients will be enrolled in the second stage of the study. Assessment of efficacy will be conducted every 3 cycles (approximately every 12 weeks) with CT chest/ abdomen/pelvis. Safety including clinic visits, and exams will occur every 4 weeks on Day 1 of each cycle. Laboratory testing will be performed every 2 weeks for the first 2 cycles and then on Day 1 of each subsequent cycle.
What are clinical trials?
Clinical trials are research studies that test new drugs, treatments or medical procedures to determine their effectiveness and safety. Clinical cancer trials are conducted only after their design meets the approval of the U.S. Food and Drug Administration (FDA).
These research studies help inform doctors and scientists about new and emerging cancer therapies, how those therapies should be used, and which patients will benefit the most from these approaches. Almost every standard
cancer treatment currently in use was first made available to patients who participated in clinical trials.
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