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. 

In order to participate in the OASIS Breast Cancer Trial certain Inclusion and Exclusion criteria must be met. Eligibility criteria help to keep study volunteers as safe as possible.

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.

What are the possible benefits of participating in a clinical trial?

Potential benefits of participating in a well-designed and well-executed clinical trial include:
However, volunteers understand that there may not be any benefit to participating in a study and there may be risks associated with that therapy.

Clinical Trial Frequently Asked Questions

People with the condition being studied or healthy people can volunteer to take part in a clinical trial. Each study has specific entry requirements such as age or a medical condition necessary for participation. The doctor in charge of the study must review the volunteers’ medical history to determine if he/she is eligible to participate based on strict study conditions called entry criteria. For full list of inclusion and exclusion criteria for this trial, please visit https://bit.ly/OASIStrial
A medical doctor is usually responsible for carrying out the study according to the study protocol. Before a clinical trial can begin to enroll volunteers an Institutional Review Board (IRB) must approve it. The IRB is a committee made of healthcare experts that review each study to protect patient rights and ensure the safety of research volunteers. The IRB also ensures the research is scientifically sound and is involved in the review of safety issues throughout the study.
One of the documents the RB must review and approve is called an Informed Consent Form. This form is provided to volunteers who are interested in participating in a clinical trial program. The informed consent includes everything a volunteer needs to know about the study such as risk and potential benefits, so that he/she can make an informed decision as to whether or not to participate. The process allows volunteers to ask questions. Volunteers are encouraged to take their time in making a decision before signing the consent and joining the study. You and your family should feel completely comfortable with your decision to participate before you sign the consent.
After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about the need for further testing. After a phase I or I| trial, the researchers decide whether to move on to the next phase or to stop testing the treatment or procedure because it was unsafe or not effective. When a phase Ill trial is completed, the researchers examine the information and decide whether the results have medical importance. Results from clinical trials are often published in peer-reviewed scientific journals. Peer review is a process by which experts review the report before it is published to ensure that the analysis and conclusions are sound. If the results are particularly important, they may be featured in the news, and discussed at scientific meetings and by patient advocacy groups before or after they are published in a scientific journal. Once a new approach has been proven safe and effective in a clinical trial, it may become a new standard of medical practice. Ask the research team members if the study results have been or will be published. Published study results are also available by searching for the study’s official name or Protocol ID number in the National Library of Medicine’s PubMed® database.
There are federal rules in place to help protect the rights and safety of people who take part in clinical trials. Learn about informed consent, institutional review boards (IRB’s), and how trials are closely monitored.
If you are thinking about taking part in a clinical trial, be sure to ask your doctor, “Is there clinical trial that I can join?” If your doctor offers you a trial, here are some questions you may want to ask. Questions provided by NCl. (https://www.cancer.gov/about-cancer/treatment/clinical-trials/questions)
More information on this clinical trial can be found on clinicaltrials.gov. ClinicalTrials.gov Identifier: NCT04720664

Study Locations

This is a multi-site clinical trial. Please enter your information to find the a study site near you.

District of Columbia

MedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center

MedStar Washington Hospital Center

Maryland

MedStar Franklin Square Medical Center

MedStar Good Samaritan Hospital

New Jersey

Hackensack University Medical Center