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Study of the effect and tolerability of INT230-6 by direct injection into the tumor, followed by neoadjuvant treatment with chemoimmunotherapy in patients with early-stage triplenegative breast cancer: open-label, randomized phase II study involving two groups of participants (cohorts)
EU CTIS ID: 2024-512511-49-00
What this study is testing
The primary objective of this study is to determine the clinical activity of intratumoral INT230-6 in patients with early TNBC.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- 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.
- 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.
- 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.
- Male or female subject Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
You likely can't join if
- Inflammatory Breast Cancer cT4d
- History of (non-infectious) pneumonitis and tuberculosis.
- Known history of allogeneic organ or stem cell transplant.
- Diagnosis of immunodeficiency, concomitant or prior use of immunosuppressive medication within 7 days before registration.
- Unfavorable relation between tumor and breast size, or close contact of the tumor and skin per judgment of the investigator and breast surgeon.
- 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.
See the full eligibility criteria
- 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
- 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.
- 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.
- 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.
- Male or female subject Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate bone marrow function, hepatic and renal function
- Negative pregnancy test (for women only)
- Sufficient cardiac function
- Inflammatory Breast Cancer cT4d
- History of (non-infectious) pneumonitis and tuberculosis.
- Known history of allogeneic organ or stem cell transplant.
- Diagnosis of immunodeficiency, concomitant or prior use of immunosuppressive medication within 7 days before registration.
- Unfavorable relation between tumor and breast size, or close contact of the tumor and skin per judgment of the investigator and breast surgeon.
- 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.
- Any concomitant drugs contraindicated for use with the trial drug according to the Investigator Brochure (IB).
- Known hypersensitivity to trial drug or to any component of the trial drug.
- 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.
- Concurrent bilateral breast cancer
- Concomitant treatment with any other experimental drug for recent breast cancer diagnosis in another clinical trial.
- 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.
- Active autoimmune disease that required systemic treatment in the past 2 years
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.