Table of contents
- Trial overview
- Who can participate
- What is being measured
- Treatment combinations in the study
- Study phase and size
- Patient-friendly explanation of key terms
Trial overview
The available study is an interventional clinical trial called MORPHEUS-panBC, which is designed to evaluate the efficacy and safety of multiple treatment combinations in patients with metastatic breast cancer.[1]
The study status is Authorised, and the planned enrollment is 325 participants.[1]
This trial is in Phase 1, which means it is an early-stage study that mainly focuses on safety and early signs of benefit.[1]
Who can participate
The trial is for people with metastatic breast cancer, meaning breast cancer that has spread to other parts of the body.[1]
The study includes several breast cancer groups: triple negative breast cancer (TNBC), hormone receptor positive breast cancer (HR+ BC), and HER2 positive or HER2-low breast cancer.[1]
These groups matter because different breast cancer types may respond differently to treatment combinations.[1]
What is being measured
The main efficacy measure in Stage 1 is objective response rate (ORR), which means the share of patients whose cancer gets smaller or disappears during treatment.[1]
The study also measures adverse events, which are unwanted medical problems that happen during the trial, along with their nature and severity.[1]
Severity is assessed using the NCI CTCAE v4.0, a standard system used in cancer trials to grade side effects and other medical problems.[1]
In Stage 1 and Stage 2, the study also checks changes from baseline in vital signs, ECG parameters, and targeted clinical laboratory test results.[1]
Treatment combinations in the study
The trial tests multiple treatment combinations rather than just one treatment plan.[1]
The listed study drugs include ATIRMOCICLIB-related combinations with several other cancer medicines such as fulvestrant, palbociclib, ribociclib, abemaciclib, letrozole, atezolizumab, sacituzumab govitecan, paclitaxel, inavolisib, empagliflozin, metformin, and tocilizumab.[1]
Some treatments are given by mouth, while others are given by injection or infusion into a vein.[1]
The source data does not provide a separate description of which exact combination is assigned to each patient in this summary, but it shows that the trial is comparing several treatment combinations in the same study.[1]
Study phase and size
Because this is a Phase 1 study, the main goal is to learn more about safety and early activity in patients with metastatic breast cancer.[1]
The planned enrollment of 325 people suggests a relatively large early-stage cancer study.[1]
The study is interventional, which means researchers actively give treatments and then measure what happens.[1]
Patient-friendly explanation of key terms
Efficacy means how well a treatment works against the cancer.[1]
Safety means how well people tolerate the treatment and what medical problems may happen during the study.[1]
Baseline means the starting point before treatment begins, so later changes can be compared with it.[1]
ECG is a heart test that records the heart’s electrical activity.[1]
Laboratory abnormalities are test results that are outside the normal range and may need medical attention.[1]
