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

NCT03742986 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 17-00890
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Breast Cancer

Keywords

Nivolumab

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Had a Pathological Complete Response (pCR)

  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).

  up to 16 weeks

• Number of Participants Who Had a Pathological Complete Response (pCR)

  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).

  up to 1 year

Study Arms (2)

HER2-negative, including TNBC or HR-positive

EXPERIMENTAL

Drug: Nivolumab 360mg; Drug: Paclitaxel 80mg/m^2; Drug: Doxorubicin 60mg/m^2; Drug: Cyclophosphamide 600mg/m^2

HER2-positive, independent of HR status

EXPERIMENTAL

Drug: Nivolumab 360mg; Drug: Doxorubicin 60mg/m^2; Drug: Cyclophosphamide 600mg/m^2; Drug: Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2; Drug: Trastuzumab 8mg/kg and 6 mg/kg; Drug: Pertuzumab 840mg and 420mg

Interventions

Nivolumab 360mg DRUG

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

HER2-negative, including TNBC or HR-positive; HER2-positive, independent of HR status

Paclitaxel 80mg/m^2 DRUG

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

HER2-negative, including TNBC or HR-positive

Doxorubicin 60mg/m^2 DRUG

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

HER2-negative, including TNBC or HR-positive; HER2-positive, independent of HR status

Cyclophosphamide 600mg/m^2 DRUG

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

HER2-negative, including TNBC or HR-positive; HER2-positive, independent of HR status

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)

HER2-positive, independent of HR status

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

HER2-positive, independent of HR status

Pertuzumab 840mg and 420mg DRUG

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

HER2-positive, independent of HR status

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

Indiana University

Bloomington, Indiana, 47405, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Nivolumab; Paclitaxel; Doxorubicin; Cyclophosphamide; Docetaxel; Trastuzumab; pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Maryann Kwa, MD
• Organization: NYU Langone Health - Perlmutter Cancer Center

maryann.kwa@nyulangone.org

(212) 731-6364

Study Officials

• Maryann Kwa

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 15, 2018
• Study Start: May 2, 2019
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: December 19, 2023
• Results First Posted: February 25, 2022

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Data will be available as specified in publication

Locations

US (2)