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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Nivolumab 360mg; Drug: Paclitaxel 80mg/m^2; Drug: Cyclophosphamide 600mg/m^2; Drug: Doxorubicin 60mg/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

• Registration Number: NCT03742986
• Lead Sponsor: NYU Langone Health

Brief Summary

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

Detailed Description

The purpose of this study is to determine whether the addition of nivolumab to chemotherapy improves pathologic complete response (pCR) in the breast and post-therapy lymph nodes evaluated histologically (ypT0/Tis ypN0) in patients with inflammatory breast cancer (IBC).

Study Timeline

• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-15
• Study Start: 2019-05-02
• Results First Submitted: 2022-01-05
• Results First Submitted QC: 2022-02-02
• Results First Posted: 2022-02-25
• Primary Completion: 2023-06-12
• Study Completion: 2023-06-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• 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

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Exclusion Criteria

• 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
• Known hypersensitivity to the components of the study drugs(s)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HER2-positive, independent of HR status	Cyclophosphamide 600mg/m^2	-
HER2-positive, independent of HR status	Pertuzumab 840mg and 420mg	-
HER2-positive, independent of HR status	Nivolumab 360mg	-
HER2-negative, including TNBC or HR-positive	Paclitaxel 80mg/m^2	-
HER2-negative, including TNBC or HR-positive	Nivolumab 360mg	-
HER2-positive, independent of HR status	Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2	-
HER2-negative, including TNBC or HR-positive	Doxorubicin 60mg/m^2	-
HER2-negative, including TNBC or HR-positive	Cyclophosphamide 600mg/m^2	-
HER2-positive, independent of HR status	Doxorubicin 60mg/m^2	-
HER2-positive, independent of HR status	Trastuzumab 8mg/kg and 6 mg/kg	-

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (2)

Indiana University; 🇺🇸 Bloomington, Indiana, United States

NYU Langone Health; 🇺🇸 New York, New York, United States