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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

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

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

NCT ID

NCT03742986

First Posted

November 14, 2018

Last Updated

June 30, 2023

Sponsor

NYU Langone Health

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

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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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