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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06358573 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage CT1C N1-3 M0 or CT2-4C N0-3 M0 is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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