Clinical trial · Interventional
Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients
Adaptive Phase II Randomized Non-comparative Trial of Nivolumab After Induction Treatment in Triple-negative Breast Cancer (TNBC) Patients: TONIC-trial
NCT02499367CI-TRIAL-00057250TONICunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single center non-blinded randomized non-comparative phase II trial. The first stage of the trial consists of five arms ( with induction treatment followed by nivolumab, 1 with no induction treatment before nivolumab). For the second stage, the number of arms will be reduced based on the results obtained in the first stage.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Low dose doxorubicin | Drug | Doxorubicin | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- Radiation therapy
- description
- Radiotherapy on metastatic lesion
- interventionNames
- Drug: Nivolumab
- Radiation: Radiation therapy
- type
- ACTIVE_COMPARATOR
- label
- Low dose doxorubicin
- description
- 15mg flat dose, once weekly for 2 weeks
- interventionNames
- Drug: Nivolumab
- Drug: Low dose doxorubicin
- type
- ACTIVE_COMPARATOR
- label
- Cyclophosphamide
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic triple negative breast cancer with confirmation of Estrogen Receptor (ER) and HER2 negativity on a histological biopsy of a metastatic lesion * 18 years or older * Metastatic lesion accessible for histological biopsy (Mandatory biopsies: pre-induction treatment, post-induction treatment, 6-weeks. Optional biopsies: 12-weeks, at progression, of irradiated site). The pre-induction treatment biopsy has to contain sufficient tumor content (≥100 tumor cells); subjects with samples that have insufficient tumor content will require re-biopsy prior to induction treatment. Interval between last treatment and pre-induction biopsy has to be at least 14 days * One, two or three line(s) of chemotherapy for metastatic disease and with progression of disease on last treatment regimen * Evaluable disease according to RECIST 1.1 * Metastatic lesion accessible for radiation with 1x20 Gray or 3x8 Gray * Subjects with brain metastases are eligible if these are not symptomatic. Subjects who received prior treatment for brain metastases should be free of progression on magnetic resonance imaging (MRI) for at least 4 weeks after treatment is completed and prior to first dose of study drug administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (\> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration. * WHO performance status of 0 or 1 * Adequate bone marrow function * Adequate hepatic function * Adequate renal function * Signed written informed consent 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 an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody * live vaccine within 30 days of planned start of study therapy. * active other cancer * positive test for hepatitis B surface virus surface antigen (HBsAg) or hepatitis * history of uncontrolled serious medical or psychiatric illness * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * current pregnancy or breastfeeding.
References
Publications (1)
- DERIVEDLin AY, Isaeva OI, Deger T, Geurts VCM, Vessies DCL, Voorwerk L, Slagter M, Moore KS, van der Leest P, Martens JWM, van den Broek D, Wessels LFA, Kok M. CfDNA-based copy-number dynamics during anti-PD1 treatment in metastatic triple negative breast cancer. Cell Rep Med. 2025 Dec 16;6(12):102512. doi: 10.1016/j.xcrm.2025.102512. PMID 41406937