NCI-2020-03770

The COMPASSHER2 Trials (Comprehensive Use of Pathologic Response Assessment To Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 And Placebo Compared With T-DM1 and Tucatinib

The COMPASSHER2 Trials are a series of research studies focused on a certain type of breast cancer called HER2-positive breast cancer. This trial is a double-blinded, Phase III randomized trial. One group of patients gets a medicine called T-DM1 along with a placebo. T-DM1 is a medicine that treats Her2 positive breast cancer - so both groups get the standard treatment for Her2 positive breast cancer. The other group of patients also gets T-DM1, but in addition, they get a medicine called Tucatinib. Neither group knows whether they're getting the real medicine or the placebo. The goal of this study is to find out if adding Tucatinib to T-DM1 works better than just T-DM1 alone in treating HER2-positive breast cancer. They'll look at things like how well the cancer responds to treatment, how long it takes for the cancer to come back, and how the patients are doing during the treatment.

HER-2 Negative: It is a type of breast cancer where cancer cells have normal levels of the protein called HER-2. Cancer cells that are HER-2 negative grow more slowly and are less likely come back or spread to other parts of the body than cancers that have too much HER-2.

Double-Blinded: Neither the patients nor the doctors know who is getting what treatment. This helps make sure the results are completely not biased

Randomized: Patients are randomly assigned to one of two groups. It's like flipping a coin to decide who gets which treatment

A Placebo: is a substance or treatment that has no active medical properties but is given to a patient as if it were a real medication or treatment. It is often used in medical research to compare the effects of a new drug or treatment with the effects of no treatment at all. The idea is to see if the new drug or treatment is genuinely effective by comparing how patients who receive the real treatment fare compared to those who receive the placebo

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT04457596

NCI-2020-03770

Clinical Trial Site: Mount Sinai/Columbia

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