drugset / Trial / NCT06358573
Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK
RandomizedParallel-groupOpen-labelTreatment
Summary
About 10-20% of all individuals with breast cancer have a so-called triple-negative tumor (TNBC). This type of breast cancer has a particularly unfavorable course and a higher mortality rate compared to other forms of breast cancer. Research studies show that it is important for individuals with TNBC to achieve a so-called pathologic complete response (pCR) to treatment. In the phase II study SAKK 66/22, it is being investigated whether the administration of the drug INT230-6 before surgery for breast cancer can increase the rate of pCR in the tumor and affected lymph nodes. The tolerability of INT230-6 as well as other factors such as response to treatment and the possibility of breast-conserving surgery are also being examined.
Timeline
- Start
- 2024-10-24
- Primary completion
- 2028-10
- Completion
- 2031-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | INT230-6 | Unknown | — | Other |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cyclophospahmide | Unknown | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Epirubicin | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |
| Background | Pembrolizumab | Monoclonal antibody | — | — |