Table of contents
- Trial overview
- Who was studied
- What was tested
- Study phase and design
- Main endpoints
- Trial status and size
Trial overview
The trial studied Rp1 together with atezolizumab in the neo-adjuvant setting for early-stage triple-negative breast cancer.[1] Neo-adjuvant means treatment given before surgery.[1]
The study title describes this as oncolytic immunotherapy, but the source data mainly show that the trial tested the combination of Rp1 and atezolizumab before surgery in this cancer group.[1]
Who was studied
The trial enrolled patients with early-stage triple-negative breast cancer.[1] This means the study focused on people whose breast cancer was found at an early stage and had the triple-negative type.[1]
The source data do not give the full list of entry rules, so we can only say that the study population was early-stage triple-negative breast cancer patients.[1]
What was tested
The intervention list includes atezolizumab and vusolimogene oderparepvec, which the trial title and summary connect to Rp1.[1] The brief summary says the safety run-in was designed to evaluate the safety and toxicity of the combination Atezolizumab plus RP1 oncolytic immunotherapy.[1]
In simple terms, the researchers were checking whether the treatment combination could be given safely before surgery and whether it might help reduce the amount of cancer left behind.[1]
Study phase and design
This was an interventional study, which means the researchers gave a treatment and then measured what happened.[1] The trial was a Phase 2 study and also included a safety run-in part.[1]
A safety run-in is an early part of a study used to check safety before the main part continues.[1] In this trial, that early step looked at the combination of Atezolizumab plus Rp1.[1]
Main endpoints
The safety run-in endpoint was the incidence, nature, and severity of adverse events, with severity graded using NCI CTCAE v5.0.[1] This means the study counted unwanted medical problems, described what they were, and measured how serious they were.[1]
The Phase 2 endpoint was the residual cancer burden, or RCB 0-1 rate, at the time of surgery in patients with no increase in ctDNA after cycle 3.[1] Residual cancer burden means how much cancer is still present after treatment, and ctDNA is cancer-related DNA found in the blood.[1]
The brief summary adds that the main Phase 2 goal was to measure the rate of RCB 0-1 at definitive surgery in subjects who had completed at least one cycle of treatment.[1]
Trial status and size
The trial is listed as completed.[1] It enrolled 51 participants.[1]
Because the study is completed, the source data focus on the trial plan, target group, and outcome measures rather than final results.[1]
