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SAKK 66/22: 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
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512511-49-00
Acronym
U1111-1305-0044
Enrollment
25
Registered
2025-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early triple-negative breast cancer (TNBC)

Brief summary

Pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0).

Detailed description

pCR (invasive and in-situ, only invasive, respectively) in the breast, pCR in lymph nodes, Pattern of non pCR, Radiological response according to RECIST v1.1, Radiological tumor response using two perpendicular diameters, EFS, Rate of breast conserving surgery (BCS) at the time of definitive surgery, Conversion of intention for mastectomy to BSC and axillary lymph node dissection (ALND) to sentinel lymph node dissection (SLND) or tailored axillary surgery (TAS) after treatment, Adverse events according to National Cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Interventions

None listed

Sponsors

Swiss Cancer Institute
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0).

Secondary

MeasureTime frame
pCR (invasive and in-situ, only invasive, respectively) in the breast, pCR in lymph nodes, Pattern of non pCR, Radiological response according to RECIST v1.1, Radiological tumor response using two perpendicular diameters, EFS, Rate of breast conserving surgery (BCS) at the time of definitive surgery, Conversion of intention for mastectomy to BSC and axillary lymph node dissection (ALND) to sentinel lymph node dissection (SLND) or tailored axillary surgery (TAS) after treatment, Adverse events according to National Cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026