Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC) (NCT03742986) | Clinical Trial Compass
CompletedPhase 2
Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
United States8 participantsStarted 2019-05-02
Plain-language summary
Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Number of Participants Who Had a Pathological Complete Response (pCR)
Timeframe: up to 16 weeks
2
Number of Participants Who Had a Pathological Complete Response (pCR)