NCT06358573

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

Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early Triple-negative Breast Cancer (TNBC). An Open-label Randomized Two-cohort Phase 2 Clinical Trial. INVINCIBLE-4-SAKK

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Triple-negative breast cancer (TNBC) poses significant challenges due to its aggressiveness, high relapse rates, and increased mortality. The Keynote-522 study revealed a 19.6% incidence of event-free survival (EFS) events in early-stage TNBC patients over 39 months. Achieving pathological complete response (pCR) and clearing positive lymph nodes are crucial prognostic factors. The IMP INT230-6 is a combination of the chemotherapeutic agents cisplatin and vinblastine, along with a molecule that facilitates their distribution in tumor tissue. INT230-6, currently in clinical trials, has demonstrated the ability to induce up to 95% necrosis in T2 breast cancer tumors and it has been observed to stimulate systemic immune activation during the period between diagnosis and surgery. Moreover, promising results have been seen in seven refractory breast cancer patients, resulting in decreased Ki67 levels and a median overall survival of 12 months. Completed and ongoing U.S. clinical trials including 91 patient a window-of-opportunity trial demonstrate the safety and early activity of INT230-6, both alone and with checkpoint inhibitors like pembrolizumab and ipilimumab, particularly in resistant cases. Based on the positive outcomes, it will be assessed within this clinical trial the safety and early clinical activity of INT230-6 in early TNBC patients, addressing the high unmet medical need in this challenging subtype.

Conditions

• Triple-negative Breast Cancer
• TNBC - Triple-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	INT230-6	INT230-6 is a formulation consisting of an proprietary amphiphilic cell penetration enhancer molecule, 8-((2-hydroxybenzoyl)amino)octanoate, also referred to as SHAO, combined with cisplatin and vinblastine sulfate. The IMP is without marketing authorization in Switzerland and anywhere in the world.
OTHER	neoadjuvant immuno-chemotherapy	Standard of care

Timeline

• Start date: 2024-10-24
• Primary completion: 2028-10-01
• Completion: 2031-12-01
• First posted: 2024-04-10
• Last updated: 2026-04-02

Locations

9 sites across 1 country: Switzerland