A study to compare a type of monitoring with or without endocrine therapy (COMET) for non-invasive breast cancer patients (DCIS)
144 study locations across the U.S.
Trial Summary
The study will look at the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with a set of chemotherapy and endocrine therapy in the treatment of adults who have a certain type of high-risk, early-stage breast cancer that is estrogen receptor-positive and human epidermal growth factor receptor 2-negative (ER+/HER2-). The study assigns patients into two groups differing by the type of drug they receive in combination with a type of chemotherapy.
Trial Design
1200 participants with low-risk DCIS will be divided into two groups: the first group of patients will receive surgery with or without a choice of endocrine therapy, while the second group will receive only a choice of endocrine therapy with Active Monitoring (AM).
Inclusion Criteria
1. Are 40 to 99 years old
2. Are female
3. Are able to reas and speak Spanish or English
Exclusion Criteria
1. Are male
2. Diagnosed with invasive breast cancer in either breast
Exclusion criteria are conditions or characteristics if they apply to you, may likely make you ineligible to participate in the study.
Inclusion criteria is a checklist of items, if they apply to you, may make you eligible to be included for the study.