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

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Solid Tumor; Gastrointestinal Cancer; Gynecological Malignancies; High-Risk Cancer; Myelosuppression
• Intervention / Treatment: Drug: Empegfilgrastim

• Study Type: Observational
• Enrollment (Anticipated): 285

Contacts and Locations

• Study Contact: Name: Lyudmila Zhukova, MD, PhD, professor; Phone Number: +74953043035; Email: lyudmila.zhukova@mail.ru

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Not yet recruiting
    • FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation
    • Contact: Svetlana Khlokhlova, MD, PhD
    • Principal Investigator: Svetlana Khlokhlova, MD, PhD
  • Not Required
    • Moscow, Not Required, Russian Federation, 111123
      • Recruiting
      • Moscow Clinical Scientific Center named after AS Loginov
      • Contact: Lyudmila Zhukova, MD, PhD, professor
    • Moscow, Not Required, Russian Federation
      • Recruiting
      • FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
      • Contact: Alexey Tryakin, MD, PhD, professor
      • Contact: Inna Ganshina, MD, PhD
      • Principal Investigator: Mikhail Fedyanin, MD, PhD, professor
      • Principal Investigator: Inna Ganshina, MD, PhD
      • Principal Investigator: Alexey Tryakin, MD, PhD, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with high and "gray zone" risk reccurrence breast cancer, gastointestinal cancers and gynecological malignancies who are prescribed myelosuppressive therapy with empegfilgrastim supportive therapy to support planned RDI, reduce the frequency, duration of neutropenia, the incidence of febrile neutropenia (FN) and infections manifested by FN, as part of routine clinical practice according to the approved indications of the appropriate drugs.

Description

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 х 10(9) /L;
   • Platelets ≥ 100 х 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with high and "gray zone" risk reccurrence early breast cancer	Drug: Empegfilgrastim; Extimia®
Patients with gastointestinal cancers	Drug: Empegfilgrastim; Extimia®
Patients with gynecological malignancies	Drug: Empegfilgrastim; Extimia®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Any grade adverse events frequency	18 months
Serious adverse events frequency	18 months
Frequency of study withdrawal due to adverse events	18 months
The incidence of severe infections (grade 3-4)	18 months
Frequency of antibiotic prescription	18 months
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
Completed cases number of (neo) adjuvant therapy	18 months
RCB rate in patients with breast cancer	18 months

Collaborators and Investigators

• Sponsor: Moscow Clinical Scientific Center
• Investigators: Principal Investigator: Inna Ganshina, MD, PhD, FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia; Study Chair: Lyudmila Zhukova, MD, PhD, professor, Moscow Clinical Scientific Center named after AS Loginov; Principal Investigator: Alexey Tryakin, MD, PhD, professor, FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia; Principal Investigator: Mikhail Fedyanin, MD, PhD, professor, FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia; Principal Investigator: Svetlana Khokhlova, MD, PhD, FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Breast Diseases; Neoplasms; Breast Neoplasms; Gastrointestinal Neoplasms
• Other Study ID Numbers: DS_v01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No