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

NCT03742986 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-12-19

Study results available
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Summary

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

Conditions

Interventions

DRUG

Nivolumab 360mg

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

DRUG

Paclitaxel 80mg/m^2

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

DRUG

Doxorubicin 60mg/m^2

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

DRUG

Cyclophosphamide 600mg/m^2

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

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)

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

DRUG

Pertuzumab 840mg and 420mg

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

Sponsors & Collaborators

Principal Investigators

  • Maryann Kwa · NYU Langone Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2023-06-12
Completion
2023-06-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03742986 on ClinicalTrials.gov