drugset / Trial / NCT06358573

Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK

NCT06358573

Phase 2 Recruiting 61 enrolled Swiss Cancer Institute
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

EvaluationDrugModalityDoseRoute
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