Vinblastine sulfate; Cisplatin for Early triple-negative breast cancer (TNBC)

Inclusion criteria

• {"criterion_text":"- Newly histologically diagnosed, previously untreated locally advanced nonmetastatic TNBC as defined by the most recent American Society of Clinical Oncology (ASCO) / College of American Pathologist (CAP) guidelines"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Multifocal and multicentric primary tumors are allowed and the tumor with the most advanced T stage should be used to assess the eligibility. If multifocal or multicentric disease TNBC needs to be confirmed for each focus."}
• {"criterion_text":"- Measurable disease in the breast with at least one lesion with a diameter ≥2cm1.5cm that is evaluable per RECIST v1.1, visible in ultrasound and injectable."}
• {"criterion_text":"- Male or female subject Age ≥ 18 years."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0-1"}
• {"criterion_text":"- Adequate bone marrow function, hepatic and renal function"}
• {"criterion_text":"- Negative pregnancy test (for women only)"}
• {"criterion_text":"- Sufficient cardiac function"}

Exclusion criteria

• {"criterion_text":"- Inflammatory Breast Cancer cT4d"}
• {"criterion_text":"- Concomitant anticoagulation with warfarin or equivalent vitamin K antagonist, direct thrombin inhibitors or platelet inhibitors/antiplatelet agents that cannot be stopped 24 hours before the administration of IMP."}
• {"criterion_text":"- Any concomitant drugs contraindicated for use with the trial drug according to the Investigator Brochure (IB)."}
• {"criterion_text":"- Known hypersensitivity to trial drug or to any component of the trial drug."}
• {"criterion_text":"- Prior chemotherapy, targeted therapy, radiation therapy or anti-PD-L1 agent for previous breast cancer or Ductal Carcinoma in Situ (DCIS) on the same side."}
• {"criterion_text":"- Concurrent bilateral breast cancer"}
• {"criterion_text":"- Concomitant treatment with any other experimental drug for recent breast cancer diagnosis in another clinical trial."}
• {"criterion_text":"- Known history of human immunodeficiency virus (HIV) or active chronic hepatitis C or hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous (iv) antimicrobial treatment."}
• {"criterion_text":"- Active autoimmune disease that required systemic treatment in the past 2 years"}
• {"criterion_text":"- History of (non-infectious) pneumonitis and tuberculosis."}
• {"criterion_text":"- Known history of allogeneic organ or stem cell transplant."}
• {"criterion_text":"- Diagnosis of immunodeficiency, concomitant or prior use of immunosuppressive medication within 7 days before registration."}

Primary endpoints

• {"endpoint_text":"- Pathological complete response (pCR) in the primary tumor (ypT0/Tis) and affected lymph nodes (ypN0).","definition_or_measurement_approach":"Pathological assessment of the primary tumor and affected lymph nodes to determine ypT0/Tis and ypN0 (pathological complete response, pCR)."}

Secondary endpoints

• {"endpoint_text":"- pCR (invasive and in-situ, only invasive, respectively) in the breast","definition_or_measurement_approach":"Pathological assessment of breast tissue to determine pCR (invasive and in-situ or only invasive as specified)."}
• {"endpoint_text":"- pCR in lymph nodes","definition_or_measurement_approach":"Pathological assessment of lymph nodes to determine pCR."}
• {"endpoint_text":"- Pattern of non pCR","definition_or_measurement_approach":"Characterisation of residual disease pattern when pCR is not achieved (as defined in protocol)."}
• {"endpoint_text":"- Radiological response according to RECIST v1.1","definition_or_measurement_approach":"Radiological tumor response assessed using RECIST v1.1 criteria."}
• {"endpoint_text":"- Radiological tumor response using two perpendicular diameters","definition_or_measurement_approach":"Measurement of tumor response using two perpendicular diameters on imaging."}
• {"endpoint_text":"- EFS","definition_or_measurement_approach":"Event-free survival (EFS) measured per protocol-defined criteria."}
• {"endpoint_text":"- Rate of breast conserving surgery (BCS) at the time of definitive surgery","definition_or_measurement_approach":"Proportion of participants undergoing breast-conserving surgery at definitive surgery."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Assessment of changes in surgical intent/procedures after treatment (mastectomy to BCS; ALND to SLND or TAS)."}
• {"endpoint_text":"- Adverse events according to National Cancer institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0","definition_or_measurement_approach":"Safety assessed by recording adverse events and grading them using NCI CTCAE v5.0."}

France

Earliest CTIS Part Ii Submission Date

13-03-2025

Latest Decision Or Authorization Date

14-10-2025

Processing Time Days

215

Number Of Sites

6

Number Of Participants

25

Switzerland

Primary sponsor

Full Name

Swiss Cancer Institute

Organisation Type

Patient organisation/association

Country Of Registered Address

Switzerland

Third parties

• {"country":"","full_name":"Intensity Therapeutics","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Sakk","duties_or_roles":"Source of monetary support","organisation_type":""}