CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Nivolumab 360mg +6 moredrug
Likely dose
Nivolumab 360mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03742986
NCT03742986Phase 2Completed
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Phase II Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)

NYU Langone Health·interventional·Posted Nov 15, 2018·Updated Dec 19, 2023

In Brief

A Phase 2 clinical trial evaluating Nivolumab 360mg, Paclitaxel 80mg/m^2, and 5 other interventions for Breast Cancer. Completed, enrolled 8 participants across 2 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 15, 2018
Enrollment StartMay 2, 2019
Primary CompletionJun 12, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.6 years ago

Interventions

Nivolumab 360mgdrug

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

Paclitaxel 80mg/m^2drug

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

Doxorubicin 60mg/m^2drug

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

Cyclophosphamide 600mg/m^2drug

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

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

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/kgdrug

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 420mgdrug

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