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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742986
• Other study ID #: 17-00890
• Status: Completed
• Phase: Phase 2
• Start date: May 2, 2019
• Est. completion date: June 12, 2023

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 12, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Nivolumab 360mg
Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
• Paclitaxel 80mg/m^2
Paclitaxel 80mg/m^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
• Doxorubicin 60mg/m^2
Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
• Cyclophosphamide 600mg/m^2
Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8)
• Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2
Paclitaxel 80mg/m^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m^2 on Day 1 of every 21 day cycle (Cycle 1-4)
• Trastuzumab 8mg/kg and 6 mg/kg
Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4
• Pertuzumab 840mg and 420mg
Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4

Locations

Country	Name	City	State
United States	Indiana University	Bloomington	Indiana
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Had a Pathological Complete Response (pCR)	pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0).	up to 16 weeks
Primary	Number of Participants Who Had a Pathological Complete Response (pCR)	pCR is defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy (ypT0/Tis ypN0).	up to 1 year