Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00935 | Registry Identifier | NCI CTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
| Amgen | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical research study is to learn how effective the combination of chemotherapy including both panitumumab, Abraxane (nab-paclitaxel), and carboplatin (PNC) and fluorouracil, epirubicin, and cyclophosphamide (FEC) used before surgery for the treatment of IBC is. The safety of PNC combination will also be studied.
Study Drugs:
Panitumumab is designed to prevent or slow down the growth of tumor cells by blocking the proteins on the surface the cancer cell, called the epidermal growth factor receptor (EGFR).
Nab-paclitaxel is designed to kill tumor cells by binding a chemotherapy drug paclitaxel to albumin, a protein made by the liver. The albumin gets into the cancer cell and releases the paclitaxel directly to the tumor.
Carboplatin is designed to stop or slow cancer cells from growing by damaging the RNA or DNA (the genetic material of cells) that tells the tumor cells to grow.
5-fluorouracil, epirubicin, and cyclophosphamide each work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Study Drug Administration:
On Day 1 of Week 1, you will receive panitumumab through a needle in your vein over 60 minutes.
After Week 1, you will receive a total of 4 cycles of PNC. Each cycle is 4 weeks.
During Cycles 1-3 (Weeks 2-13), you will receive PNC by vein once a week for 3 weeks, followed by a week of rest. You will receive PNC through a needle in your vein. The infusion will take 90 minutes.
During Cycle 4 (Week 14 to 17), you will receive PNC on Day 1 of Weeks 14 and 15. On Day 1 of Week 16, you will receive only carboplatin and nab-paclitaxel.
Starting on Day 1 of Week 18, you will receive FEC through a needle in your vein. The infusion will take 90 minutes. You will receive a total of 4 cycles, each 3 weeks long, over 12 weeks.
Surgery:
After you have completed both PNC and FEC treatments, you will have the standard of care surgery performed. You will be given a separate consent form to read and sign.
During surgery, breast tissue samples will be collected to identify tumors as routine procedure.
Study Visits:
Each week that you receive PNC or FEC therapy, before each dose of chemotherapy, blood (about 1 1/2 tablespoons) will be drawn for routine tests.
Before Week 2, an optional breast core biopsy will be performed to collect tumor samples for biomarker testing
On Week 2, every 4 weeks after that until the end of PNC, and again before FEC, the following tests and procedures will be performed before each dose of chemotherapy.
During Weeks 2 and 9, and before FEC therapy, the study doctor will take pictures of both of your breasts.
Before FEC (after Cycle 4 of PNC) and again before surgery, the following tests and procedures will be performed:
This schedule may be changed if the study doctor thinks that it is necessary.
Length of the study:
You may remain on study treatment for up to 10 months. You will be taken off study early if the disease gets worse or you experience intolerable side effects.
This is an investigational study. Panitumumab is FDA approved and commercially available for the treatment of EGFR-expressing metastatic colorectal cancer with disease progression. It's use in this study is considered to be investigational.
Nab-paclitaxel is FDA approved and commercially available for the treatment of breast cancer after the failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. The use of Nab-paclitaxel in this study is considered to be investigational.
Carboplatin is FDA approved and commercially available for the treatment of IBC.
FEC is FDA approved for breast cancer in general, but not specifically for inflammatory breast cancer.
The use of PNC and FEC together before surgery is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PNC + FEC | Experimental | PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and FEC = 5-fluorouracil, epirubicin, and cyclophosphamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panitumumab | Drug | 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Achieved Pathologic Complete Response (CR) | Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field. | Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events (AEs) | AEs were graded according to the National Cancer Institute's Common Terminology Criteria (CTCAE), version 3.0. All AEs (>/=2 non-hematological and >/=3 hematological AEs) occurring after informed consent signing observed by the investigator or reported by the subject whether or not attributed to investigational product. Full AE reporting can be found in the Adverse Event Section. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Naoto Ueno, MD, PHD | M.D. Anderson Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29879283 | Derived | Matsuda N, Wang X, Lim B, Krishnamurthy S, Alvarez RH, Willey JS, Parker CA, Song J, Shen Y, Hu J, Wu W, Li N, Babiera GV, Murray JL, Arun BK, Brewster AM, Reuben JM, Stauder MC, Barnett CM, Woodward WA, Le-Petross HTC, Lucci A, DeSnyder SM, Tripathy D, Valero V, Ueno NT. Safety and Efficacy of Panitumumab Plus Neoadjuvant Chemotherapy in Patients With Primary HER2-Negative Inflammatory Breast Cancer. JAMA Oncol. 2018 Sep 1;4(9):1207-1213. doi: 10.1001/jamaoncol.2018.1436. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
47 participants were accrued and assessed for eligibility. 7 participants were ineligible and excluded ( 3 had HER2-positive disease, 2 had metastatic disease, and 2 did not receive financial approval for treatment.
Recruitment Period: November 2010- July 2015. All recruitment was done at The University of Texas MD Anderson Cancer Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PNC + FEC | PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and FEC = 5-fluorouracil, epirubicin, and cyclophosphamide Panitumumab: 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12. Nab-paclitaxel: 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes. Carboplatin: AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line. 5-Fluorouracil: 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). Epirubicin: 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). Cyclophosphamide: 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PNC + FEC | PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and FEC = 5-fluorouracil, epirubicin, and cyclophosphamide Panitumumab: 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12. Nab-paclitaxel: 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes. Carboplatin: AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line. 5-Fluorouracil: 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). Epirubicin: 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). Cyclophosphamide: 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 That Achieved Pathologic Complete Response (CR) | Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field. | Posted | Count of Participants | Participants | Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment). |
|
Serious adverse events (SAEs) were captured from the time of the first protocol-specific intervention, until 30 days after the last dose of drug, unless the participant withdrew consent, an average of 8 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PNC + FEC | PNC = Panitumumab + Nab-paclitaxel + Carboplatin, and FEC = 5-fluorouracil, epirubicin, and cyclophosphamide Panitumumab: 2.5 mg/kg IV on Day 1 of Week 1 over 60 minutes, followed by 2.5 mg/kg weekly Weeks 2-12. Nab-paclitaxel: 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes. Carboplatin: AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line. 5-Fluorouracil: 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). Epirubicin: 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). Cyclophosphamide: 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding per rectum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Naoto Ueno, Professor, Breast Medical Oncology | UT MD Anderson Cancer Center | (713) 792-8754 | nueno@mdanderson.org |
Not provided
| 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 30, 2018 | Jul 7, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D058922 | Inflammatory Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077544 | Panitumumab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| D016190 | Carboplatin |
| D005472 | Fluorouracil |
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nab-paclitaxel | Drug | 100 mg/m2 IV over 30 min on Day 1 of Weeks 2-13 over 30 minutes. |
|
|
| Carboplatin | Drug | AUC 2 IV over 30 min on Day 1 of Weeks 2-13 after completion of Abraxane through separate IV line. |
|
|
| 5-Fluorouracil | Drug | 500 mg/m2 IV every 3 weeks, starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). |
|
|
| Epirubicin | Drug | 100 mg/m2 IV over 30 min every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). |
|
|
| Cyclophosphamide | Drug | 500 mg/m2 IV every 3 weeks starting on Day 1 of Week 14 (4 cycles, each 3 weeks long, over 12 weeks). |
|
|
| Before each cycle of Panitumumab, nab-paclitaxel and carboplatin (PNC) & fluorouracil, epirubicin and cyclophosphamide (FEC) until 30 days after the last dose of drug, an average of 8 months, unless the participant withdraw consent. |
| 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 |
|
| Menopausal Status | Count of Participants | Participants |
|
| Clinical N Category | N1, N2, N3: Refers to the number and location of lymph nodes that contain cancer. The higher the number after the N, the more lymph nodes that contain cancer. | Count of Participants | Participants |
|
| Clinical TNM Stage at Presentation | Clinical Stage for inflammatory breast cancer was determined by the presence of distant metastases at initial diagnosis. Stage III was confined to the regional area and stage IV had distant metastases. Stage IV was considered worse outcomes. | Count of Participants | Participants |
|
| Nuclear Grade | A low grade number (grade 1) usually means the cancer is slower-growing and less likely to spread. A high grade number (grade 3) means a faster-growing cancer that's more likely to spread. An intermediate grade number (grade 2) means the cancer is growing faster than a grade 1 cancer but slower than a grade 3 cancer. | Count of Participants | Participants |
|
| Primary Tumor Subtype | Count of Participants | Participants |
|
|
|
| Secondary | Number of Participants With Treatment-related Adverse Events (AEs) | AEs were graded according to the National Cancer Institute's Common Terminology Criteria (CTCAE), version 3.0. All AEs (>/=2 non-hematological and >/=3 hematological AEs) occurring after informed consent signing observed by the investigator or reported by the subject whether or not attributed to investigational product. Full AE reporting can be found in the Adverse Event Section. | Posted | Count of Participants | Participants | Before each cycle of Panitumumab, nab-paclitaxel and carboplatin (PNC) & fluorouracil, epirubicin and cyclophosphamide (FEC) until 30 days after the last dose of drug, an average of 8 months, unless the participant withdraw consent. |
|
|
|
| 0 |
| 40 |
| 15 |
| 40 |
| 39 |
| 40 |
| Cellulitis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Delirium | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Kidney stone | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| MDS | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sycope | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Vulvar abscess | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophil count decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemoglobin decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelet count decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypersensitivity | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hand-and-foot syndrome | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D056831 | Coordination Complexes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004317 | Doxorubicin |
| 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 |