A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab plus Chemotherapy vs Placebo plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)

To join this study, you would generally need to be an adult, 18 years old or older, with a diagnosis of Triple Negative Breast Cancer.

While the study aims to include a wide range of adults, there might be other specific criteria, such as the stage of your cancer, your general health, and whether you've had certain other treatments in the past. These details help ensure the study is safe for you and that the results are clear and reliable.

Both men and women can participate, as breast cancer can affect anyone.

If you decide to take part in this study, you would receive several different medications. These include standard chemotherapy drugs like Cyclophosphamide, Epirubicin, Doxorubicin, Carboplatin, and Paclitaxel, along with medications to help manage side effects like Pegfilgrastim or Filgrastim. You would also receive either Pembrolizumab (Keytruda), the immune-boosting drug being tested, or a placebo (an inactive substance that looks just like Pembrolizumab, given with saline or dextrose).

The study involves regular visits to the clinic for your treatments and to have your health checked. Doctors would monitor your response to treatment through various assessments, including blood tests, scans, and physical examinations. A key part of the study involves surgery after the initial treatment phase. After surgery, you would continue with either Pembrolizumab or the placebo for a period to see if it prevents the cancer from returning. You would also fill out questionnaires about your quality of life to see how the treatments affect your daily living. The total duration of your involvement could be several months for active treatment, followed by a longer period of follow-up visits to monitor your health and any cancer recurrence.