/, General/ACE for metastatic IBC
2018-11-05T09:01:43+00:00By |
Alternative Drug Names:

Atezolizumab is also known as Tecentriq. Cobimetinib is also known as Cotellic. Eribulin is also called Halavan.

Purpose of Trial:

This is a trial of a novel combination for chemotherapy-resistant metastatic IBC. The purpose is to determine the efficacy and safety of using these 3 drugs together that have never been used at the same time.

Why this study is relevant for IBC patients:

Metastatic HER2-negative IBC is aggressive and usually needs multiple drugs to successfully control it. This trial is a combination of an immunotherapy, targeted therapy and known active chemotherapy. Immunotherapy is a very active area of study in IBC that shows much promise, especially when combined with other types of drugs.

Scientific Details:

Atezolizumab is a type of immunotherapy drug called a checkpoint inhibitor. It targets PD-L1 which is expressed on tumors and some type of immune cells which normally functions to keep T cells inactive, and therefore allow the tumor to hide from the immune system. Cobimetinib is a targeted therapy that targets the MEK pathway. MEK is known to promote metastasis and is an important survival pathway for many cancers. MEK inhibitors also increase the amount of PD-L1, so by combining Atezolizumab and Cobimetinib together, these drugs work better together. Eribulin is a common choice of chemotherapy for metastatic IBC that works via blocking cell division and also affects the blood vessels.

Trial Information:

This is a phase 2 study of 3 drugs that are already FDA approved but not in this combination for breast cancer. Everyone will receive all 3 active drugs. The starting dose of all 3 are fixed, but cobimetinib may be dose-reduced if the early patients have severe toxicities.

Logistics:

The first 4 weeks of the study are called the PD window, when you will only receive Atezolizumab and Cobimetinib, the 2 targeted drugs. There is a mandatory biopsy at baseline and after the PD window (prior to week 5 treatment). The purpose of the PD window is to determine whether the 2 targeted drugs are hitting their targets. Atezolizumab is given by vein every 2 weeks throughout the whole study. Cobimetinib is an oral pill that you will take daily for 3 weeks on, and 1 week off. After this period, Eribulin, is added onto this regimen and it is given on a 2 weeks on, 1 week off schedule (i.e. on days 1 and 8 of a 21 day cycle). After 4 cycles of eribulin if you are still doing well, the eribulin will be dropped and you will go into what is called the maintenance phase, and only receive the 2 targeted drugs again. At this point, visits become less frequent every 2 weeks for treatment and every 4 weeks for a physical exam with the doctor.

Location of Trial:

Only at MD Anderson in Houston, TX (NCI Comprehensive Cancer Center)

For more information:

Contact the principal investigator, Dr Bora Lim at 713-563-0744 or study coordinator Angela Alexander at 713-792-9137.

Is this study NCI Compliant?:

Yes

NCT trial number & link:

NCT03202316 click for more info

Poster from scientific meeting:

Not available