Trial · NCT03742986

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

NCT03742986, Phase 2, Completed, NYU Langone Health; results first posted 2022-02-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC). Trials, record NCT03742986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03742986

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of Nivolumab With Chemotherapy as Neoadjuvant Treatment in Inflammatory Breast Cancer (IBC)
NCT number: NCT03742986
Status: Completed
Phases: Phase 2
Enrollment: 8 participants, actual
Lead sponsor: NYU Langone Health
Conditions: Breast Cancer
Interventions: 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
First posted: 2018-11-15
Last updated: 2023-12-19
Results first posted: 2022-02-25

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Who Had a Pathological Complete Response (pCR)	up to 16 weeks	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).
Primary	Number of Participants Who Had a Pathological Complete Response (pCR)	up to 1 year	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).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Who Had a Pathological Complete Response (pCR)	up to 16 weeks		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Who Had a Pathological Complete Response (pCR)	up to 1 year		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Number of Participants Who Had a Pathological Complete Response (pCR)	HER2-negative, Including TNBC or HR-positive	0	Participants
Number of Participants Who Had a Pathological Complete Response (pCR)	HER2-positive, Independent of HR Status	3	Participants
Number of Participants Who Had a Pathological Complete Response (pCR)	HER2-negative, Including TNBC or HR-positive	1	Participants
Number of Participants Who Had a Pathological Complete Response (pCR)	HER2-positive, Independent of HR Status	3	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	HER2-negative, Including TNBC or HR-positive	4
Overall Study	STARTED	HER2-positive, Independent of HR Status	4
Overall Study	COMPLETED	HER2-negative, Including TNBC or HR-positive	4
Overall Study	COMPLETED	HER2-positive, Independent of HR Status	4
Overall Study	NOT COMPLETED	HER2-negative, Including TNBC or HR-positive	0
Overall Study	NOT COMPLETED	HER2-positive, Independent of HR Status	0

Source ClinicalTrials.gov

Adverse events150

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	HER2-negative, Including TNBC or HR-positive	2	4
other	Anemia	Blood and lymphatic system disorders	HER2-positive, Independent of HR Status	1	4
other	Febrile Neutropenia	Blood and lymphatic system disorders	HER2-negative, Including TNBC or HR-positive	4	4
other	Febrile Neutropenia	Blood and lymphatic system disorders	HER2-positive, Independent of HR Status	4	4
other	Atrial Fibrilation	Cardiac disorders	HER2-negative, Including TNBC or HR-positive	4	4
other	Atrial Fibrilation	Cardiac disorders	HER2-positive, Independent of HR Status	1	4
other	Myocardial Infarction	Cardiac disorders	HER2-negative, Including TNBC or HR-positive	3	4
other	Myocardial Infarction	Cardiac disorders	HER2-positive, Independent of HR Status	4	4
other	Palpitations	Cardiac disorders	HER2-negative, Including TNBC or HR-positive	3	4
other	Palpitations	Cardiac disorders	HER2-positive, Independent of HR Status	3	4

1 to 10 of 150Source ClinicalTrials.gov

See all 150 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	HER2-negative, Including TNBC or HR-positive	0	4
Total, all-cause mortality	HER2-positive, Independent of HR Status	0	4
Total, other adverse events	HER2-negative, Including TNBC or HR-positive	4	4
Total, other adverse events	HER2-positive, Independent of HR Status	4	4
Total, serious adverse events	HER2-negative, Including TNBC or HR-positive	1	4
Total, serious adverse events	HER2-positive, Independent of HR Status	3	4

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
HER2-negative, Including TNBC or HR-positive vs HER2-positive, Independent of HR Status: Number of Participants Who Had a Pathological Complete Response (pCR)	Trial comparisons
HER2-negative, Including TNBC or HR-positive vs HER2-positive, Independent of HR Status: Number of Participants Who Had a Pathological Complete Response (pCR)	Trial comparisons
HER2-negative, Including TNBC or HR-positive vs HER2-positive, Independent of HR Status: deaths from any cause	Trial comparisons
HER2-negative, Including TNBC or HR-positive vs HER2-positive, Independent of HR Status: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03742986

GET https://conductscience.org/api/trials/v1/NCT03742986/events?page=2

API reference For AI assistants