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

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.

NCT Number	NCT06358573
Lead Sponsor	Swiss Cancer Institute
Conditions	Triple-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer
Enrollment	61 participants
Start Date	2024-10-24
Primary Completion	2028-10 (estimated)
Study Completion	2031-12 (estimated)
Updated on ClinicalTrials.gov	2026-04-02