NeoAdjuvant Therapy Comparing Sacituzumab Govitecan+Pembrolizumab vs. SoC Chemotherapy in Clinical Stage II-III, Triple-negative Early Breast Cancer

This study is for adults aged 18 or over who have been diagnosed with triple-negative breast cancer. Your cancer must be in stage II or III (meaning it's not spread to other parts of your body). You'll need to have had some initial chemotherapy (called neo-adjuvant chemotherapy) that included drugs like carboplatin and pembrolizumab or paclitaxel and pembrolizumab.

There are two main groups within the study. One group is for people with stage II cancer who have responded really well to the first 12 weeks of treatment. The other group is for people with stage III cancer, or stage II cancer that didn't respond as well to the first 12 weeks. You'll need to be able to understand information about the study and complete questionnaires.

To check if you're eligible, doctors will need to confirm your cancer type is triple-negative based on tests. You'll also need a preserved tissue sample of your tumour for review. Lastly, your general health needs to be good enough to take part in a study like this.

If you decide to take part in this study, what happens next depends on which group you're in.

**For Cohort 1 (De-escalation)**: If you have stage II cancer and your tumour has shrunk significantly after the first 12 weeks of chemotherapy (carboplatin/paclitaxel plus pembrolizumab), the study will investigate if you can skip further chemotherapy before surgery. You would then proceed directly to surgery. After surgery, if tests show no cancer cells left, you wouldn't receive further chemotherapy beyond standard follow-up. If some cancer cells remain, you might receive additional standard treatments, which could include more chemotherapy or a different drug (olaparib, if you have a specific gene mutation).

**For Cohort 2 (Intensification)**: This group is for everyone with stage III cancer, and those with stage II cancer whose tumour hasn't shrunk as much after the initial 12 weeks of treatment. You would be randomly assigned to one of two treatment paths. One path involves receiving a new drug combination – Sacituzumab Govitecan and Pembrolizumab – before surgery. The other path involves receiving current standard chemotherapy before surgery. After surgery, depending on whether cancer cells are still present, you would receive further standard post-surgery treatments which might include more chemotherapy or another drug.

Throughout the study, you'll have regular hospital visits for check-ups, scans, and to receive your treatment. Doctors will closely monitor your health and any side effects. The total duration of your participation, including follow-up, will be explained by the study team, but clinical trials generally involve long-term monitoring to track outcomes like cancer recurrence.