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