Health Condition 1: null- Early Stage Breast Cancer Health Condition 2: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: SPI-2012 (Eflapegrastim): SPI-2012 (Eflapegrastim) is a novel biologic that was produced using the proprietary long-acting protein/peptide discovery technology (LAPSCOVERYâ?¢), which wa
Sponsors
Spectrum Pharmaceuticals Inc
Spectrum Oncology Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient must have a newly diagnosed, histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer. 2. Patient must be a candidate to receive adjuvant or neoadjuvant TC chemotherapy. 3. Patient must have adequate hematological, renal and hepatic function 4. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 5. Females of childbearing potential must have a negative urine pregnancy test within 30 days prior to randomization
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, 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-asparaginase, 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 trial-specified therapies). 4. Patient has locally recurrent/metastatic or contralateral breast cancer 5. Patient with previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development 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 |
|---|---|
| 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 1Timepoint: Duration of Severe Neutropenia (DSN) in Cycle 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 patientâ??s lowest ANC in Cycle 1 3. Incidence of Febrile Neutropenia (FN) in patients during Cycle 1Timepoint: End of Cycle 1 | — |
Countries
Canada, Hungary, India, Poland, United States of America
Contacts
Public ContactDr Gaurav Kadam
Spectrum Oncology Pvt Ltd
Outcome results
None listed