Breast Cancer Clinical Trial

Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)

Summary

Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC

View Full Description

Full Description

The purpose of this study is to determine whether the addition of nivolumab to chemotherapy improves pathologic complete response (pCR) in the breast and post-therapy lymph nodes evaluated histologically (ypT0/Tis ypN0) in patients with inflammatory breast cancer (IBC).

View Eligibility Criteria

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)

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

8

Study ID:

NCT03742986

Recruitment Status:

Completed

Sponsor:

NYU Langone Health

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 2 Locations for this study

See Locations Near You

Indiana University
Bloomington Indiana, 47405, United States
NYU Langone Health
New York New York, 10016, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

8

Study ID:

NCT03742986

Recruitment Status:

Completed

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider