Clinical trial NCT04905329: A Multicenter Prospective Post-registration Study of Empegfilgrastim to Evaluate Safety and Efficacy in Special Cancer Populations
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solid Tumor
High-Risk Cancer
Breast Cancer
Gastrointestinal Cancer
Gynecological Malignancies
Myelosuppression
Lead sponsor: Moscow Clinical Scientific Center
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Relative dose-intensity (RDI) of the myelosupressive therapy course
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 18 months
measure: RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to (neo) adjuvant therapy of colorectal cancer
timeFrame: 18 months
measure: RDI of FOLFOX-, FOLFOXIRI-based regimens performed in relation to patients with potentially resectable liver metastases of colorectal cancer
timeFrame: 18 months
measure: RDI of DCF-, FOLFORINOX-based regimens performed in relation to therapy of pancreatic cancer
timeFrame: 18 months
measure: RDI of DCF-, FOLFORINOX-, FLOT-, FOLFOX-based regimens performed in relation to therapy of gastric and esophageal cancers
timeFrame: 18 months
measure: RDI of chemotherapy courses performed in patients with cervical cancer and sarcoma of the uterus after irradiation of the pelvic organs
timeFrame: 18 months
measure: The complete pathological responses (pCR) rate in the primary tumors for patients diagnosed with HER2 + and triple negative early breast cancer requiring neoadjuvant treatment
timeFrame: 18 months
measure: 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
timeFrame: 18 months
measure: The incidence of febrile neutropenia with empegfilgrastim supportive therapy compared with historical control
timeFrame: 18 months
measure: 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
timeFrame: 18 months
measure: Completed cases number of (neo) adjuvant therapy
timeFrame: 18 months
measure: The incidence of severe infections (grade 3-4)
timeFrame: 18 months
measure: Frequency of antibiotic prescription
timeFrame: 18 months
measure: Frequency of study withdrawal due to adverse events
timeFrame: 18 months
measure: RCB rate in patients with breast cancer
timeFrame: 18 months
measure: Any grade adverse events frequency
timeFrame: 18 months
measure: Serious adverse events frequency
timeFrame: 18 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Clinical Scientific Center named after AS Loginov
state: Not Required
city: Moscow
country: Russian Federation
facility: FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
state: Not Required
city: Moscow
country: Russian Federation
facility: FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation
Study officials:
affiliation: FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
name: Inna Ganshina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moscow Clinical Scientific Center named after AS Loginov
name: Lyudmila Zhukova, MD, PhD, professor
role: STUDY_CHAIR
affiliation: FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
name: Alexey Tryakin, MD, PhD, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: FSBI NMITs oncology named after N.N. Blokhin, the Ministry of Health of Russia
name: Mikhail Fedyanin, MD, PhD, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: FSBI "National medical research center for obstetrics, gynecology and perinatology named after academician VI Kulakov" Ministry of healthcare of the Russian Federation
name: Svetlana Khokhlova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: