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

Breast Cancer Clinical Trial

— Def_Special  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04905329
• Other study ID #: DS_v01
• Status: Recruiting
• Start date: April 28, 2020
• Est. completion date: September 1, 2023

Study information

• Verified date: May 2021
• Source: Moscow Clinical Scientific Center
• Contact: Lyudmila Zhukova, MD, PhD, professor
• Phone: +74953043035
• Email: lyudmila.zhukova[@]mail.ru
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 285
• Est. completion date: September 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Signed informed consent form;

2. Histologically verified diagnosis;

3. 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;

4. ECOG performance 0-2;

5. Haematology:

• ANC = 1,5 ? 10(9) /L;

• Platelets = 100 ? 10(9) /L;

• Hemoglobin = 90 g/L;

6. 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:

1. Documented hypersensitivity to empegfilgrastim, filgrastim, pegfilgrastim, and / or their constituent excipients: pegylated drugs, protein recombinant drugs;

2. Systemic use of antibiotics less than 72 hours before the first drug administration in the study;

3. 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;

4. Concurrent participation in clinical trials, participation in clinical trials within the previous 30 days, previous participation in this study;

5. 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;

6. History of bone marrow or hematopoietic stem cell transplantation;

7. Presence of acute or active chronic infections;

8. 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;

9. Inability to administer the drug by intravenous infusion or subcutaneous injection.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Gynecological Malignancies
• High-Risk Cancer
• Myelosuppression
• Neoplasms
• Solid Tumor

Intervention

Drug:
• Empegfilgrastim
Extimia®

Locations

Country	Name	City	State
Russian Federation	FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation	Moscow
Russian Federation	FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia	Moscow	Not Required
Russian Federation	Moscow Clinical Scientific Center named after AS Loginov	Moscow	Not Required

Sponsors (1)

Lead Sponsor	Collaborator
Moscow Clinical Scientific Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative dose-intensity (RDI) of the myelosupressive therapy course		12 months
Secondary	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
Secondary	RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to (neo) adjuvant therapy of colorectal cancer		18 months
Secondary	RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to patients with potentially resectable liver metastases of colorectal cancer		18 months
Secondary	RDI of DCF-, FOLFORINOX-based regimens performed in relation to therapy of pancreatic cancer		18 months
Secondary	RDI of DCF-, FOLFORINOX-, FLOT-, FOLFOX-based regimens performed in relation to therapy of gastric and esophageal cancers		18 months
Secondary	RDI of chemotherapy courses performed in patients with cervical cancer and sarcoma of the uterus after irradiation of the pelvic organs		18 months
Secondary	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
Secondary	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
Secondary	The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control		18 months
Secondary	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
Secondary	Completed cases number of (neo) adjuvant therapy		18 months
Secondary	The incidence of severe infections (grade 3-4)		18 months
Secondary	Frequency of antibiotic prescription		18 months
Secondary	Frequency of study withdrawal due to adverse events		18 months
Secondary	RCB rate in patients with breast cancer		18 months
Secondary	Any grade adverse events frequency		18 months
Secondary	Serious adverse events frequency		18 months