Actively Recruiting
Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK
Led by Swiss Cancer Institute · Updated on 2026-04-02
61
Participants Needed
9
Research Sites
370 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent according to country specific law and ICH GCP E6(R2) regulations before registration and prior to any trial specific procedures.
- Newly histologically diagnosed, previously untreated locally advanced non-metastatic TNBC as defined by the most recent ASCO/CAP guidelines.
- Breast cancer stages included: cT1c (1.5-2cm) N1-3 M0 or cT2-4c N0-3 M0.
- Multifocal and multicentric primary tumors allowed if TNBC confirmed for each focus.
- Measurable disease in the breast with at least one lesion ≥ 1.5cm, visible in ultrasound and injectable.
- Male or female subjects aged 18 years or older.
- ECOG performance status 0-1.
- Adequate bone marrow function: neutrophil count ≥ 1.5 x 10^9/L; platelet count ≥ 100 x 10^9/L; hemoglobin ≥ 90 g/L.
- Adequate liver function: total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN if total bilirubin >1.5 x ULN; AST and ALT ≤ 2.5 x ULN; albumin ≥ 30 g/L; LDH <2.5 x ULN.
- Adequate kidney function: eGFR ≥ 50 ml/min/1.73 m2.
- Adequate heart function: left ventricular ejection fraction ≥ 50% by echocardiography.
- Adequate coagulation function: INR ≤ 1.5 x ULN unless on anticoagulant therapy; aPTT ≤ 1.5 x ULN unless on anticoagulant therapy.
- Women of childbearing potential must use effective contraception, not be pregnant or breastfeeding, and have a negative pregnancy test before inclusion.
- Men must agree to use effective contraception during treatment and for 6 months after last dose.
You will not qualify if you...
- Inflammatory breast cancer cT4d.
- Tumor size or location unfavorable for breast conserving surgery as judged by physician or surgeon.
- Certain TNBC histological subtypes: classic adenoid cystic carcinoma, secretory carcinoma, low-grade adenosquamous carcinoma, tall cell carcinoma with reversed polarity, high-grade metaplastic.
- History of invasive cancer within 3 years except treated basal or squamous cell skin cancer or in situ cervical cancer.
- Prior chemotherapy, targeted therapy, radiation, or anti-PD-L1 agents for previous breast cancer or DCIS on the same side.
- Concurrent bilateral breast cancer.
- Use of other experimental drugs for recent breast cancer diagnosis.
- Severe or uncontrolled cardiovascular disease including congestive heart failure NYHA II-IV, recent heart attack or stenting, serious arrhythmias, significant QT prolongation, uncontrolled hypertension.
- Known HIV or active chronic hepatitis B or C infection or uncontrolled active systemic infection.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- History of pneumonitis requiring steroids or current pneumonitis.
- Known tuberculosis history.
- History of allogeneic organ or stem cell transplant.
- Receipt of live attenuated vaccine within 30 days prior to registration.
- Diagnosis of immunodeficiency or recent use of immunosuppressive medication except certain corticosteroids.
- Use of anticoagulants that cannot be stopped 24 hours before INT230-6 administration except aspirin ≤ 300 mg/day.
- Use of drugs contraindicated with trial drug or immuno-chemotherapy.
- Known allergy to trial drug or immuno-chemotherapy components.
- Incapacitated adults or serious medical, psychiatric, psychological, familial, or geographic conditions interfering with the study or treatment compliance.
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Tumor Zentrum Aarau
Aarau, Switzerland, 5000
Terminated
2
St. Claraspital
Basel, Switzerland, 4058
Actively Recruiting
3
EOC - IOSI Ospedale regionale Bellinzona e valli - San Giovanni
Bellinzona, Switzerland, 6500
Actively Recruiting
4
Kantonsspital Graubünden
Chur, Switzerland, 7000
Actively Recruiting
5
Kantonsspital Baselland
Liestal, Switzerland, 4410
Actively Recruiting
6
HOCH Health Ostschweiz
Sankt Gallen, Switzerland, 9007
Actively Recruiting
7
TBZO - Tumor- & Brustzentrum Ostschweiz
Sankt Gallen, Switzerland, 9016
Terminated
8
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Actively Recruiting
9
Universitätsspital Zürich - Klinik für Gynäkologie
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
J
Jana Musilova, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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