Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients

• Status: Recruiting
• Trial end date: 2026-12-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a single center non-blinded randomized multi-cohort non-comparative phase II trial with a Simon's two-stage design.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Collaborator: Bristol-Myers Squibb
• Treatments: Cisplatin; Doxorubicin; Liposomal doxorubicin; Nivolumab

Criteria

Inclusion Criteria:

• Metastatic or incurable locally advanced triple negative breast cancer (ER < 10%, HER2 IHC 0,1+ or 2+ with no amplification)

• Metastatic lesion accessible for histological biopsy

• 18 years or older

• Maximum of three lines of chemotherapy for metastatic disease and with evidence of progression of disease. Treatment with low-dose doxorubicin in the palliative setting is not allowed.

• WHO performance status of 0 or 1

• Measurable or evaluable disease according to RECIST 1.1

• Disease Free Interval (defined as time between first diagnosis or locoregional recurrence and first metastasis) longer than 1 year

• Subjects with brain metastases are eligible if these are not symptomatic and free of progression of at least 4 weeks

• A maximum dosage of 360 mg/m2 of anthracyclines and no previous anthracycline-related cardiac toxicity. In case of radiation in the cardiac area, hypertension, diabetes mellitus or hypercholesterolemia, the left ventricular ejection fraction must be 50% or higher.

• Adequate bone marrow, kidney and liver function

Exclusion Criteria:

• uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris

• known history of leptomeningeal disease localization

• history of having received other anticancer therapies within 2 weeks of start of the study drug

• history of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mgl daily prednisone equivalents) or chronic infections.

• prior treatment with immune checkpoint inhibitors.

• active other cancer

• history of uncontrolled serious medical or psychiatric illness

• current pregnancy or breastfeeding