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Study of efficacy of nivolumab with neoadjuvant chemotherapy in patients with IBC
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2-negative, including TNBC or HR-positive | Experimental |
| |
| HER2-positive, independent of HR status | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab 360mg | Drug | Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maryann Kwa | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Bloomington | Indiana | 47405 | United States | ||
| NYU Langone Health |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Immediately following publication. No end date.
Data will be available as specified in publication
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2020 |
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| 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 |
|
| New York |
| New York |
| 10016 |
| United States |
| FG001 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | up to 16 weeks |
|
|
| ||||||||||||||||||||||||||||||
| 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). | Posted | Count of Participants | Participants | up to 1 year |
|
16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) | 0 | 4 | 1 | 4 | 4 | 4 |
| EG001 | 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 | 0 | 4 | 3 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Allergic Reaction | General disorders | Non-systematic Assessment |
| ||
| Mediport Site Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Shortness of Breath (Dyspnea) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Febrile Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Atrial Fibrilation | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Non-systematic Assessment |
| ||
| Sinus Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Stomach Pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Alanine Aminotransferase Increased | Investigations | Non-systematic Assessment |
| ||
| Allergic Reaction | General disorders | Non-systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Aspartate Aminotransferase Increased | Investigations | Non-systematic Assessment |
| ||
| Blood Bilirubin Increased | Investigations | Non-systematic Assessment |
| ||
| Bone Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Chills | General disorders | Non-systematic Assessment |
| ||
| Confusion | General disorders | Non-systematic Assessment |
| ||
| Depression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Dry Eye | Eye disorders | Non-systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
| ||
| Neutrophil Count Decreased | Investigations | Non-systematic Assessment |
| ||
| Pain in Extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Platelet Count Decreased | Investigations | Non-systematic Assessment |
| ||
| Productive Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Syncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| White Blood Cell Decreased | Investigations | Non-systematic Assessment |
| ||
| Edema Face | General disorders | Non-systematic Assessment |
| ||
| Edema Limbs | General disorders | Non-systematic Assessment |
| ||
| Fatigue | General disorders | Non-systematic Assessment |
| ||
| Fever | General disorders | Non-systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Flushing | Vascular disorders | Non-systematic Assessment |
| ||
| General Disorders and Administration Site Conditions | General disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Hot Flashes | Vascular disorders | Non-systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Infusion Related Reaction | General disorders | Non-systematic Assessment |
| ||
| Lymphocyte Count Decreased | Investigations | Non-systematic Assessment |
| ||
| Malaise | General disorders | Non-systematic Assessment |
| ||
| Mucositis Oral | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Muscle Cramp | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin infection | Infections and infestations | Non-systematic Assessment |
| ||
| Vaginal infection | Infections and infestations | Non-systematic Assessment |
| ||
| Infections and Infestations | Infections and infestations | Non-systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Other Musculoskeletal and Connective Tissue Disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Peripheral Motor Neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Peripheral Sensory Neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Urinary Tract Infection | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Reproductive System and Breast Disorders | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Pruiritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash Acneiform | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash Maculo | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin Hypopigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Folliculitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maryann Kwa, MD | NYU Langone Health - Perlmutter Cancer Center | (212) 731-6364 | maryann.kwa@nyulangone.org |
| Oct 21, 2022 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| D017239 | Paclitaxel |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|