Management of Neutropenia in Patients with Breast Cancer who receiving Chemotherapy with the Docetaxel + Cyclophosphamide MedDRA version: 20.0 Level: PT Classification code 10029354 Term: Neutropenia System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: SPI-2012 (Eflapegrastim [Rolontis™])
Product Code: SPI-2012
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Propo
Sponsors
Spectrum Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient or legally authorized representative must be willing and capable of giving written Informed Consent and must be able to adhere to dosing and visit schedules as well as meet all study requirements. 2. Patient must have a newly diagnosed histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer. 3. Patient must be a candidate to receive adjuvant or neo-adjuvant TC chemotherapy. 4. Patient (male or female) must be at least 18 years of age. 5. Patient must have adequate hematological, renal and hepatic function as defined by: _ANC =1.5×109/L _Platelet count =100×109/L _Hemoglobin >9 g/dL _Calculated creatinine clearance > 50 mL/min _Total bilirubin =1.5 mg/dL _Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) =2.5×ULN, and alkaline phosphatase =2.0×ULN 6. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =2. 7. Patient must be willing to practice two forms of contraception, one of which must be a barrier method, from study entry through 30 days after the last dose of study drug administration or 30 days after date of patient early discontinuation. 8. Females of childbearing potential must have a negative urine pregnancy test within 30 days prior to randomization. Females who are postmenopausal for at least 1 year (defined as more than 12 months since last menses) or are surgically sterilized do not require this test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 142 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 76
Exclusion criteria
Exclusion criteria: 1. Patient with an active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease. If there is a history of prior malignancies or contralateral breast cancer, the patient must be disease free for at least 5 years. 2. Patient with known sensitivity or previous reaction to Escherichia coli (E. coli) derived products (eg, filgrastim, recombinant insulin [Humulin®], L- sparaginase, somatropin [Humatrop®] growth hormone, recombinant interferon alfa-2b [Intron® A]), or any of the products to be administered during study participation. 3. Patient with concurrent adjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trialspecified therapies). 4. Patient has locally recurrent/metastatic breast cancer. 5. Patient with previous exposure to filgrastim, pegfilgrastim, or other GCSF products in clinical development within 12 months prior to the administration of study drug (SPI-2012 or pegfilgrastim). 6. Patient with an active infection or receiving anti-infectives, an underlying medical condition, or another serious illness that would impair the ability of the patient to receive protocol-specified treatment. 7. Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study. 8. Patient has had prior bone marrow or hematopoietic stem cell transplant. 9. Patient has had prior radiation therapy within 30 days prior to enrollment. 10. Patient has had major surgery within 30 days prior to enrollment. Patients who have breast surgery related to the breast cancer diagnosis or have had a port-a-cath placement may be enrolled prior to 30 days once they have fully recovered from the procedure. 11. Patient is pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of a single dose of SPI-2012 with pegfilgrastim in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC), as measured by the Duration of Severe Neutropenia (DSN) in Cycle 1; Secondary Objective: Key Secondary Objectives: To compare SPI-2012 with pegfilgrastim in: 1. Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 2. Depth of ANC Nadir, defined as the patient's lowest ANC in Cycle 1 3. Incidence of Febrile Neutropenia (FN) in patients during Cycle 1 Additional Secondary Objectives: To compare SPI-2012 with pegfilgrastim in: 1. Duration of Severe Neutropenia in Cycles 2, 3, and 4 2. Incidence of Neutropenic Complications, including anti-infective use and hospitalizations in patients during Cycle 1 3. Incidence of FN in Cycles 2, 3, and 4 4. Relative Dose Intensity (RDI) of TC in Cycles 1 to 4 5. Safety ; Primary end point(s): Comparison of the Duration of Severe Neutropenia in Cycle 1 between the SPI-2012 Treatment Arm and the Pegfilgrastim Treatment Arm. ;Timepoint(s) of evaluation of this end point: Duration of Severe Neutropenia is defined as the number of days of severe neutropenia (ANC <0.5×109/L) from the first occurrence of an ANC below the threshold. The assessment of ANC will be performed on Day 1 and Days 4 to 15 in Cycle 1. The endpoint will be measured in all patients in an Intent-to-Treat Population (ITT Population). For patients who do not meet severe neutropenia criteria, the endpoint measurement will be defined as DSN=0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoints: To compare SPI-2012 with pegfilgrastim in: 1. Time to ANC Recovery in Cycle 1 2. Depth of ANC Nadir, defined as the patient's lowest ANC in Cycle 1 3. Incidence of FN in patients during Cycle 1 The analyses of the Key Secondary Endpoints will employ a hierarchical, closed testing procedure. Additional Secondary Endpoints: To compare SPI-2012 with pegfilgrastim in: 1. Duration of Severe Neutropenia in Cycles 2, 3, and 4 2. Incidence of Neutropenic Complications, including use of antiinfectives and hospitalizations, in patients during Cycle 1 3. Incidences of FN in Cycles 2, 3, and 4 4. RDI of TC in Cycles 1 to 4 5. Safety ;Timepoint(s) of evaluation of this end point: in Cycles 1 to 4 | — |
Countries
Hungary, Poland
Contacts
Public ContactMedical Monitor
Spectrum Pharmaceuticals, Inc.
Outcome results
None listed