Phase 2
N=8
Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03742986 ↗Enrolled (actual)
8
Serious AEs
50.0%
Results posted
Feb 2022
Primary outcome: Primary: Number of Participants Who Had a Pathological Complete Response (pCR) — 0; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nivolumab 360mg (Drug); Paclitaxel 80mg/m^2 (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 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had a Pathological Complete Response (pCR) |
1; 3 | — |
| PRIMARY Number of Participants Who Had a Pathological Complete Response (pCR) |
1; 3 | — |
Summary
Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03742986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.