OncoMatch/Clinical Trials/NCT06358573
Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK
Is NCT06358573 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies INT230-6 for triple-negative breast cancer.
Treatment: INT230-6 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Disease stage
Required: Stage CT1C N1-3 M0, CT2-4C N0-3 M0 (AJCC v8)
Excluded: Stage CT4D
The following stages according to staging per American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8 are included: cT1c (1.5-2cm) N1-3 M0 or cT2-4c N0-3 M0. Inflammatory Breast Cancer cT4d [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Prior chemotherapy ... for previous breast cancer or Ductal Carcinoma in Situ (DCIS) on the same side.
Cannot have received: targeted therapy
Prior ... targeted therapy ... for previous breast cancer or Ductal Carcinoma in Situ (DCIS) on the same side.
Cannot have received: radiation therapy
Prior ... radiation therapy ... for previous breast cancer or Ductal Carcinoma in Situ (DCIS) on the same side.
Cannot have received: anti-PD-L1 agent
Prior ... anti-PD-L1 agent for previous breast cancer or Ductal Carcinoma in Situ (DCIS) on the same side.
Lab requirements
Blood counts
neutrophil count ≥ 1.5 x 10^9/L; platelet count ≥ 100 x 10^9/L; hemoglobin ≥ 90 g/L
Kidney function
eGFR ≥ 50 ml/min/1.73 m2 (CKD-EPI formula)
Liver function
total bilirubin ≤ 1.5 x ULN, or direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 x ULN; AST and ALT ≤ 2.5 x ULN; Albumin ≥ 30 g/L; LDH <2.5 ULN
Cardiac function
LVEF ≥ 50% by echocardiography (ECHO)
Adequate bone marrow function ... Adequate hepatic function ... Adequate renal function ... Adequate cardiac function ... Adequate coagulation function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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