Breast Cancer
Conditions
Keywords
Nivolumab
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).
Interventions
DRUGNivolumab 360mg
Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
DRUGPaclitaxel 80mg/m^2
Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
DRUGDoxorubicin 60mg/m^2
Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
DRUGCyclophosphamide 600mg/m^2
Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
DRUGPaclitaxel 80mg/m^2 or Docetaxel 75mg/m^2
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)
DRUGTrastuzumab 8mg/kg and 6 mg/kg
Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4
DRUGPertuzumab 840mg and 420mg
Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4
Sponsors
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HER2-negative, Including TNBC or HR-positive Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Paclitaxel 80mg/m\^2: Paclitaxel 80mg/m\^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8) | 4 |
| HER2-positive, Independent of HR Status Nivolumab 360mg: Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
Doxorubicin 60mg/m\^2: Doxorubicin 60 mg/m\^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
Cyclophosphamide 600mg/m\^2: Cyclophosphamide 600mg/m\^2 on Day 1 of every 14 day cycle (Cycle 5-8)
Paclitaxel 80mg/m\^2 or Docetaxel 75mg/m\^2: 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: 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: Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4 | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | HER2-negative, Including TNBC or HR-positive | Total | HER2-positive, Independent of HR Status |
|---|---|---|---|
| Age, Continuous | 68.2 years | 59 years | 49.75 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 6 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 2 Participants | 3 Participants | 1 Participants |
| Region of Enrollment United States | 4 participants | 8 participants | 4 participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 4 / 4 | 4 / 4 |
| serious Total, serious adverse events | 1 / 4 | 3 / 4 |
Outcome results
Primary
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).
Time frame: up to 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HER2-negative, Including TNBC or HR-positive | Number of Participants Who Had a Pathological Complete Response (pCR) | 0 Participants |
| HER2-positive, Independent of HR Status | Number of Participants Who Had a Pathological Complete Response (pCR) | 3 Participants |
Primary
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).
Time frame: up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HER2-negative, Including TNBC or HR-positive | Number of Participants Who Had a Pathological Complete Response (pCR) | 1 Participants |
| HER2-positive, Independent of HR Status | Number of Participants Who Had a Pathological Complete Response (pCR) | 3 Participants |