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

NCT ID: NCT03742986

Last Updated: 2023-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-02

Study Completion Date

2023-06-12

Brief Summary

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

Detailed Description

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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).

Conditions

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Breast Cancer

Keywords

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Nivolumab

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HER2-negative, including TNBC or HR-positive

Group Type EXPERIMENTAL

Nivolumab 360mg

Intervention Type DRUG

Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)

Paclitaxel 80mg/m^2

Intervention Type DRUG

Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)

Doxorubicin 60mg/m^2

Intervention Type DRUG

Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)

Cyclophosphamide 600mg/m^2

Intervention Type DRUG

Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)

HER2-positive, independent of HR status

Group Type EXPERIMENTAL

Nivolumab 360mg

Intervention Type DRUG

Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)

Doxorubicin 60mg/m^2

Intervention Type DRUG

Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)

Cyclophosphamide 600mg/m^2

Intervention Type DRUG

Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)

Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4

Interventions

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Nivolumab 360mg

Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)

Intervention Type DRUG

Paclitaxel 80mg/m^2

Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)

Intervention Type DRUG

Doxorubicin 60mg/m^2

Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)

Intervention Type DRUG

Cyclophosphamide 600mg/m^2

Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)

Intervention Type DRUG

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)

Intervention Type DRUG

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

Intervention Type DRUG

Pertuzumab 840mg and 420mg

Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maryann Kwa

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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Indiana University

Bloomington, Indiana, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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17-00890

Identifier Type: -

Identifier Source: org_study_id