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

Part of paid clinical trials in Bloomington, Indiana.

Sponsor
NYU Langone Health
Study ID
NCT03742986
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab 360mg — DRUG
    Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
  • Paclitaxel 80mg/m^2 — DRUG
    Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
  • Doxorubicin 60mg/m^2 — DRUG
    Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
  • Cyclophosphamide 600mg/m^2 — 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 — 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 — 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 — DRUG
    Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4

Study Details

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

Key Dates

Start date
May 2, 2019
Status verified
Nov 2023
Primary completion
Jun 12, 2023
Completion
Jun 12, 2023

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HER2-negative, including TNBC or HR-positive
  • Experimental: HER2-positive, independent of HR status

Primary Outcome Measure

Number of Participants Who Had a Pathological Complete Response (pCR) [ Time Frame: up to 16 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Indiana UniversityBloomingtonIndiana47405-
NYU Langone HealthNew YorkNew York10016-

Find similar trials in Bloomington, IN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Indiana University· Bloomington, INNYU Langone Health· New York, NY

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