Clinical trial · Interventional
Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
Phase II Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
NCT03742986CI-TRIAL-00072383completedPhase 2Results postedClinicalTrials.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)
Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide 600mg/m^2 | Drug | — | UNRESOLVED |
| Doxorubicin 60mg/m^2 | Drug | — | UNRESOLVED |
| Nivolumab 360mg | Drug | Nivolumab | ALIAS |
| Paclitaxel 80mg/m^2 | Drug | — | UNRESOLVED |
| Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2 | Drug | — | UNRESOLVED |
| Pertuzumab 840mg and 420mg | Drug | — | UNRESOLVED |
| Trastuzumab 8mg/kg and 6 mg/kg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HER2-negative, including TNBC or HR-positive
- interventionNames
- Drug: Nivolumab 360mg
- Drug: Paclitaxel 80mg/m^2
- Drug: Doxorubicin 60mg/m^2
- Drug: Cyclophosphamide 600mg/m^2
- type
- EXPERIMENTAL
- label
- HER2-positive, independent of HR status
- interventionNames
- Drug: Nivolumab 360mg
- Drug: Doxorubicin 60mg/m^2
- Drug: Cyclophosphamide 600mg/m^2
- Drug: Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2
- Drug: Trastuzumab 8mg/kg and 6 mg/kg
- Drug: Pertuzumab 840mg and 420mg
Primary outcomes (2)
- measure
- Number of Participants Who Had a Pathological Complete Response (pCR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed inflammatory breast cancer without distant metastases and have not received prior chemotherapy or immunotherapy. All breast cancer subtypes are allowed: Triple negative breast cancer (TNBC); Hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative; HR-positive or HR-negative and HER2-positive Exclusion Criteria: * Clinical or radiologic evidence of distant metastases * Malignancy that progressed within the last five years. * Cardiac disease (history of and/or active disease) * HIV positive * Neuropathy ≥ Grade 2, per the NCI CTCAE v5.0 * Allogeneic stem cell or solid organ transplantation * Autoimmune disease where in the opinion of the Investigator would preclude the use of immunotherapy * Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), or evidence of active pneumonitis * Tuberculosis * Pregnancy or lactation * Treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies * Treatment with systemic immunosuppressive medications * Cardiopulmonary dysfunction * Clinically significant history of liver disease, including cirrhosis, autoimmune hepatic disorders, HIV infection, or active Hepatitis B or Hepatitis C * Subject is pregnant or nursing * Known hypersensitivity to the components of the study drugs(s)
References
Publications (0)
Data not yet available
No reference posted for this study.