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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nivolumab 360mg
Paclitaxel 80mg/m^2
Doxorubicin 60mg/m^2
Cyclophosphamide 600mg/m^2
Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2
Trastuzumab 8mg/kg and 6 mg/kg
Pertuzumab 840mg and 420mg
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Nivolumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Indiana University
  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HER2-negative, including TNBC or HR-positive

HER2-positive, independent of HR status

Arm Description

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Full Information

First Posted
November 14, 2018
Last Updated
June 30, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03742986
Brief Title
Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
Official Title
Phase II Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
June 12, 2023 (Actual)
Study Completion Date
June 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Nivolumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HER2-negative, including TNBC or HR-positive
Arm Type
Experimental
Arm Title
HER2-positive, independent of HR status
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nivolumab 360mg
Intervention Description
Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel 80mg/m^2
Intervention Description
Paclitaxel 80mg/m^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
Intervention Type
Drug
Intervention Name(s)
Doxorubicin 60mg/m^2
Intervention Description
Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide 600mg/m^2
Intervention Description
Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Trastuzumab 8mg/kg and 6 mg/kg
Intervention Description
Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4
Intervention Type
Drug
Intervention Name(s)
Pertuzumab 840mg and 420mg
Intervention Description
Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4
Primary Outcome Measure Information:
Title
Number of Participants Who Had a Pathological Complete Response (pCR)
Description
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).
Time Frame
up to 16 weeks
Title
Number of Participants Who Had a Pathological Complete Response (pCR)
Description
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).
Time Frame
up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryann Kwa
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Data will be available as specified in publication

Learn more about this trial

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

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