Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Early- Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (RECOVER)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/2/2019 |
| Start Date: | April 13, 2017 |
| End Date: | April 25, 2019 |
Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER)
The purpose of this study is to compare the efficacy of SPI-2012 with pegfilgrastim in
patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) to
prevent and reduce Neutropenia that is associated with cancer chemotherapy.
patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) to
prevent and reduce Neutropenia that is associated with cancer chemotherapy.
This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare
the efficacy and safety of SPI-2012 with pegfilgrastim in breast cancer patients treated with
TC chemotherapy to prevent and reduce Neutropenia.
Approximately 218 patients will be enrolled and randomized in a 1:1 ratio to 2 treatment
arms:
Each cycle will be 21 days. Total 4 cycles will be evaluated for this study. On Day 1 of each
cycle, patients will receive TC chemotherapy. On Day 2 of each cycle, patients will received
study drug (SPI-2012 or pegfilgrastim).
After cycle 1, as applicable, patients who have received at least one dose of study drug will
be followed for 12 months after the last dose of study treatment for safety.
the efficacy and safety of SPI-2012 with pegfilgrastim in breast cancer patients treated with
TC chemotherapy to prevent and reduce Neutropenia.
Approximately 218 patients will be enrolled and randomized in a 1:1 ratio to 2 treatment
arms:
Each cycle will be 21 days. Total 4 cycles will be evaluated for this study. On Day 1 of each
cycle, patients will receive TC chemotherapy. On Day 2 of each cycle, patients will received
study drug (SPI-2012 or pegfilgrastim).
After cycle 1, as applicable, patients who have received at least one dose of study drug will
be followed for 12 months after the last dose of study treatment for safety.
Key Inclusion Criteria:
- New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as
operable Stage I to Stage IIIA breast cancer.
- Candidate to receive adjuvant or neo-adjuvant TC chemotherapy.
- ECOG ≤2.
- ANC ≥1.5×10^9/L.
- Platelet count ≥100×10^9/L.
- Hemoglobin >9 g/dL.
- Calculated creatinine clearance > 50 mL/min.
- Total bilirubin ≤1.5 mg/dL.
- AST/SGOT and ALT/SGPT ≤2.5×ULN. (upper limit of normal)
- Alkaline phosphatase ≤2.0×ULN.
Key Exclusion Criteria:
- Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of
the cervix) or life-threatening disease.
- Known sensitivity to E. coli derived products.
- Concurrent adjuvant cancer therapy.
- Locally recurrent/metastatic.
- Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical
development within 12 months prior to the administration of study drug.
- Active infection or any serious underlying medical condition, which would impair the
ability of the patient to receive protocol treatment.
- Prior bone marrow or stem cell transplant.
- 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.
- Prior radiation therapy within 30 days prior to enrollment.
- Major surgery within 30 days prior to enrollment.
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