A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate the efficacy and safety of Extimia® (INN - empegfilgrastim) in reducing the frequency, duration of neutropenia, the incidence of febrile neutropenia and infections caused by febrile neutropenia in patients with High and Gray Zone Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies

Official Title
-----------------
Defendor Special: A Multicenter Prospective Observational Post-registration Study of Combined Chemotherapy With Empegfilrastim Support to Evaluate Safety and Efficacy in Patients With High and Gray Zone Risk Reccurrence Breast Cancer, Gastointestinal Cancers and Gynecological Malignancies

Conditions
-----------------
Solid Tumor, High-Risk Cancer, Breast Cancer, Gastrointestinal Cancer, Gynecological Malignancies, Myelosuppression

Intervention / Treatment
-----------------
* Drug: Empegfilgrastim


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent form; Histologically verified diagnosis; Age between 18 and 80 years; If the patient had previously received chemotherapy for these indications, then it should be completed at least 30 days before the first administration of the study drug; ECOG performance 0-2; Haematology: ANC ≥ 1,5 х 10(9) /L; Platelets ≥ 100 х 10(9) /L; Hemoglobin ≥ 90 g/L; Biochemistry: Creatinine ≤ 1,5 ULN; Total bilirubin ≤ 1,5 ULN; AST/ALT ≤ 2,5 ULN; Alkaline phosphatase ≤ 5 ULN; 8. Life expectancy of at least 6 months from the date of the first drug administration in the study; 9. Ability of the patient to comply with the Protocol requirements. Exclusion Criteria: Documented hypersensitivity to empegfilgrastim, filgrastim, pegfilgrastim, and / or their constituent excipients: pegylated drugs, protein recombinant drugs; Systemic use of antibiotics less than 72 hours before the first drug administration in the study; Concurrent or less than 30 days before the start of the study, radiation therapy (with the exception of point radiation therapy for bone metastases); study; Concurrent participation in clinical trials, participation in clinical trials within the previous 30 days, previous participation in this study; Surgical treatment less than 21 days (3 weeks) prior to study enrollment; taking any experimental medications less than 30 days before enrollment in this study; History of bone marrow or hematopoietic stem cell transplantation; Presence of acute or active chronic infections; Other diseases (with the exception of the main one) that could affect the assessment of the severity of the symptoms of the underlying disease: that may mask, enhance, change the symptoms of the underlying disease or cause clinical manifestations and changes in the data of laboratory and instrumental research methods; Inability to administer the drug by intravenous infusion or subcutaneous injection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with high and gray zone risk reccurrence early breast cancer<br> | Drug: Empegfilgrastim<br>* Extimia®<br>|
| Patients with gastointestinal cancers<br> | Drug: Empegfilgrastim<br>* Extimia®<br>|
| Patients with gynecological malignancies<br> | Drug: Empegfilgrastim<br>* Extimia®<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative dose-intensity (RDI) of the myelosupressive therapy course |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RDI of 6 x TC, 6 x TCHP, ddAC x4 -> 4 x paclitaxel , dd4AC -> 4 x paclitaxel + 12 x carboplatin) regimens performed in relation to (neo) adjuvant therapy of breast cancer |  | 18 months | 
| RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to (neo) adjuvant therapy of colorectal cancer |  | 18 months | 
| RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to patients with potentially resectable liver metastases of colorectal cancer |  | 18 months | 
| RDI of DCF-, FOLFORINOX-based regimens performed in relation to therapy of pancreatic cancer |  | 18 months | 
| RDI of DCF-, FOLFORINOX-, FLOT-, FOLFOX-based regimens performed in relation to therapy of gastric and esophageal cancers |  | 18 months | 
| RDI of chemotherapy courses performed in patients with cervical cancer and sarcoma of the uterus after irradiation of the pelvic organs |  | 18 months | 
| The complete pathological responses (pCR) rate in the primary tumors for patients diagnosed with HER2 + and triple negative early breast cancer requiring neoadjuvant treatment |  | 18 months | 
| The complete pathological responses (pCR) rate in the malignant lymph nodes for patients diagnosed with HER2 + and triple negative early breast cancer requiring neoadjuvant treatment |  | 18 months | 
| The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control |  | 18 months | 
| The incidence of neutropenia leading to a dose reduction of cytostatic drugs and / or an increase of the interval between cycles when using empegfilgrastim supportive therapy compared with historical controls |  | 18 months | 
| Completed cases number of (neo) adjuvant therapy |  | 18 months | 
| The incidence of severe infections (grade 3-4) |  | 18 months | 
| Frequency of antibiotic prescription |  | 18 months | 
| Frequency of study withdrawal due to adverse events |  | 18 months | 
| RCB rate in patients with breast cancer |  | 18 months | 
| Any grade adverse events frequency |  | 18 months | 
| Serious adverse events frequency |  | 18 months |