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neoadjuvant immuno-chemotherapy / Triple Negative Breast Cancer / INT230-6 · Phase 2 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 trial registration (INVINCIBLE-4-SAKK) investigating intratumoral INT230-6 followed by neoadjuvant immuno-chemotherapy in early triple-negative breast cancer. The study is currently recruiting and has not yet reported results; it aims to evaluate whether INT230-6 increases pathological complete response (pCR) rates and improve tolerability in TNBC patients.
Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Triple-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer; age from 18 Years. Intervention: Cohort A experimental; Cohort B Standard of Care. n = 61. 10 sites: France, Switzerland.
This is a Phase 2 trial registration (INVINCIBLE-4-SAKK) investigating intratumoral INT230-6 followed by neoadjuvant immuno-chemotherapy in early triple-negative breast cancer. The study is currently recruiting and has not yet reported results; it aims to evaluate whether INT230-6 increases pathological complete response (pCR) rates and improve tolerability in TNBC patients.
No baseline characteristics, efficacy data, safety data, or outcome results are available.
This trial is investigating a novel approach (intratumoral INT230-6) to improve pCR rates in TNBC, a subtype with particularly poor prognosis. Results, when available, may inform treatment strategies for early TNBC if pCR rates are substantially improved and tolerability is acceptable.
This is a Phase 2 interventional trial registration with no results posted; the study is still recruiting and outcome data are not yet available.
As stated by the source record.
Quoted from the source exactly as published.
This trial is investigating a novel approach (intratumoral INT230-6) to improve pCR rates in TNBC, a subtype with particularly poor prognosis. Results, when available, may inform treatment strategies for early TNBC if pCR rates are substantially improved and tolerability is acceptable.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06358573). This is a study registration, not published results. Lead sponsor: Swiss Cancer Institute. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 61 participants (ESTIMATED). Conditions: Triple-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer. Interventions: DRUG: INT230-6; OTHER: neoadjuvant immuno-chemotherapy. Primary outcome measures: Pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0). , At the date of tumor assessment after surgery, estimated at 29 to 32 weeks after treatment start for cohort A and at 27 to 30 weeks after treatment start for cohort B.. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.