RecruitingPhase 2NCT06358573

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

Sponsor

Swiss Cancer Institute

Enrollment

61 participants

Start Date

Oct 24, 2024

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (INVINCIBLE-4) is testing a new drug called INT230-6 — injected directly into the tumor — combined with standard immunotherapy plus chemotherapy as treatment before surgery in patients with triple-negative breast cancer (TNBC). TNBC is an aggressive type of breast cancer that lacks three common hormone receptors, making it harder to treat. **You may be eligible if...** - You are 18 or older - You have newly diagnosed, locally advanced triple-negative breast cancer (TNBC) that has not yet been treated - Your tumor is at least 1.5 cm and fits certain staging criteria (Stage cT1c N1-3 or cT2–4c) - You have not had prior breast cancer treatment - You are in good general health **You may NOT be eligible if...** - You have metastatic (spread to distant organs) breast cancer - You have already received chemotherapy, radiation, or surgery for this cancer - You have serious heart, kidney, or liver problems - You are pregnant or breastfeeding - You have active autoimmune disease or are on long-term immune-suppressing medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGINT230-6

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.

OTHERneoadjuvant immuno-chemotherapy

Standard of care

Locations(9)

Tumor Zentrum Aarau

Aarau, Switzerland

St. Claraspital

Basel, Switzerland

EOC - IOSI Ospedale regionale Bellinzona e valli - San Giovanni

Bellinzona, Switzerland

Kantonsspital Graubünden

Chur, Switzerland

Kantonsspital Baselland

Liestal, Switzerland

HOCH Health Ostschweiz

Sankt Gallen, Switzerland

TBZO - Tumor- & Brustzentrum Ostschweiz

Sankt Gallen, Switzerland

Kantonsspital Winterthur

Winterthur, Switzerland

Universitätsspital Zürich - Klinik für Gynäkologie

Zurich, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06358573