nctId: NCT06358573 id: SAKK 66/22 briefTitle: Intratumoral INT230-6 Followed by Neoadjuvant Immuno-chemotherapy in Patients With Early TNBC. INVINCIBLE-4-SAKK overallStatus: NOT_YET_RECRUITING date: 2024-06-30 date: 2026-03 date: 2029-12 date: 2024-04-10 date: 2024-04-10 name: Swiss Group for Clinical Cancer Research class: OTHER briefSummary: 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: Triple-negative Breast Cancer conditions: TNBC - Triple-Negative Breast Cancer studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: randomized, open-label multicenter phase 2 clinical study to determine the clinical activity, safety and tolerability of INT230-6 in patients with early stage, operable TNBC who undergo neoadjuvant systemic treatment. primaryPurpose: TREATMENT masking: NONE count: 54 type: ESTIMATED name: INT230-6 name: neoadjuvant immuno-chemotherapy measure: Pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0). measure: pCR (invasive and in-situ, only invasive, respectively) in the breast measure: pCR in lymph nodes measure: Pattern of non pCR measure: Overall response according to RECIST v1.1 measure: Radiological tumor response using two perpendicular diameters measure: Event free survival (EFS) measure: Rate of breast conserving surgery (BCS) at the time of definitive surgery measure: 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 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tumor Zentrum Aarau city: Aarau zip: 5000 country: Switzerland name: Razvan Popescu, MD role: CONTACT phone: +41 62 836 78 33 email: razvan.popescu@hirslanden.ch name: Razvan Popescu, MD role: PRINCIPAL_INVESTIGATOR lat: 47.39254 lon: 8.04422 facility: St. Claraspital city: Basel zip: 4058 country: Switzerland name: Thomas Schmid, MD role: CONTACT phone: +41 61 685 88 65 email: thomas.schmid@claraspital.ch name: Thomas Schmid, MD role: PRINCIPAL_INVESTIGATOR lat: 47.55839 lon: 7.57327 facility: Istituto Oncologico della Svizzera Italiana (IOSI) city: Bellinzona zip: 6500 country: Switzerland name: Lorenzo Rossi, MD role: CONTACT phone: +41 91 811 85 77 email: lorenzo.rossi@eoc.ch name: Lorenzo Rossi, MD role: PRINCIPAL_INVESTIGATOR lat: 46.19278 lon: 9.01703 facility: Kantonsspital Graubünden city: Chur zip: 7000 country: Switzerland name: Michael Schwitter, MD role: CONTACT phone: +41 81 256 75 68 email: michael.schwitter@ksgr.ch name: Michael Schwitter, MD role: PRINCIPAL_INVESTIGATOR lat: 46.84986 lon: 9.53287 facility: Kantonsspital Baselland city: Liestal zip: 4410 country: Switzerland name: Marcus Vetter, MD role: CONTACT phone: +41 61 925 2715 email: marcus.vetter@ksbl.ch name: Marcus Vetter, MD role: PRINCIPAL_INVESTIGATOR lat: 47.48455 lon: 7.73446 facility: Kantonsspital St. Gallen city: St. Gallen zip: 9007 country: Switzerland name: Markus Jörger, MD role: CONTACT phone: +41 76 559 10 70 email: markus.joerger@kssg.ch name: Markus Jörger, MD role: PRINCIPAL_INVESTIGATOR lat: 47.42391 lon: 9.37477 facility: TBZO - Tumor- & Brustzentrum Ostschweiz city: St. Gallen zip: 9016 country: Switzerland name: Markus Niemeyer, MD role: CONTACT phone: +41 71 243 02 57 email: markus.niemeyer@tbz-ost.ch name: Markus Niemeyer, MD role: PRINCIPAL_INVESTIGATOR lat: 47.42391 lon: 9.37477 facility: Kantonsspital Winterthur city: Winterthur zip: 8401 country: Switzerland name: Ursina Zürrer, MD role: CONTACT phone: +41 52 266 25 83 email: ursina.zuerrer@ksw.ch name: Ursina Zürrer, MD role: PRINCIPAL_INVESTIGATOR lat: 47.50564 lon: 8.72413 facility: Universitätsspital Zürich - Klinik für Gynäkologie city: Zürich zip: 8091 country: Switzerland name: Isabell Witzel, Prof role: CONTACT phone: +41 43 253 64 05 email: isabell.witzel@usz.ch name: Isabell Witzel, Prof role: PRINCIPAL_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False