Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

This study is looking for adults who have locally advanced, inoperable, or metastatic (spread) triple-negative breast cancer that shows a specific marker called PD-L1. You can join if you haven't had any treatment for your advanced disease yet. If you had treatment for earlier stages of breast cancer, at least six months must have passed since that treatment.

To be considered, you should generally feel well and be able to do most of your daily activities (doctors call this an ECOG score of 0 or 1). Your body's organs, like your liver and kidneys, need to be working well. Men and women who could potentially have children must agree to use effective birth control during the study.

You cannot join if you are pregnant or breastfeeding. Also, if you've already received certain types of cancer treatments or if you're taking part in another study with a new drug or device, you usually won't be able to participate in this one. There are also specific rules about how recently you might have had other treatments like chemotherapy or radiation.

If you decide to take part, you'll be assigned to one of two treatment groups, both involving regular hospital visits. These visits will include checks by the study team, blood tests, and scans (like CT or MRI) to see how your cancer is responding and to monitor your general health. You'll receive your study medications, which will involve infusions (through a drip).

The exact number and timing of visits will depend on which treatment group you are in and how your treatment progresses. You will be closely monitored for any side effects. After your main treatment period, there will be a follow-up phase where researchers continue to track your health and cancer status, although these visits will be less frequent. The total duration of your participation will vary, continuing as long as the treatment is benefiting you and you are tolerating it well, followed by a period of observation.