TriangleNCT02953340 · CITED IN SOURCE DOCUMENTS
SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2022-03-02
The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia (DSN).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Duration of Severe Neutropenia (DSN) in Cycle 1
Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1
Depth of ANC Nadir in Cycle 1
Number of Participants With Febrile Neutropenia (FN) in Cycle 1
Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4
Number of Participants With Neutropenic Complications in Cycle 1
Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4
Relative Dose Intensity (RDI) of TC Chemotherapy
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death
Number of Participants With Clinically Significant Laboratory Abnormalities
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Key Inclusion Criteria: * New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer * Candidate for adjuvant or neo-adjuvant TC chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 * Absolute neutrophil count (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 * Aspartate aminotransferase (AST) / Serum glutamic oxaloacetic transaminase (SGOT) and Alanine aminotransferase (ALT)/Serum glutamic pyruvic transaminase (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 * Locally recurrent/metastatic breast cancer * Known sensitivity to E. coli-derived products * Concurrent adjuvant cancer therapy * 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, receiving anti-infectives, or any underlying medical condition that would impair ability 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• Radiation therapy within 30 days prior to enrollment * Major surgery within 30 days prior to enrollment
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- At each cycle for 4 cycles, participants received SPI-2012 at a fixed dose of 13.2 milligrams (mg)/0.6 milliliter (mL), \[3.6 mg granulocyte colony-stimulating factor {G-CSF}\] subcutaneously (SC) approximately 24-26 hours after receiving intravenous (IV) infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
- intervention Names
- Drug: SPI-2012
- Drug: Docetaxel
- Drug: Cyclophosphamide
- label
- (Arm 1): SPI-2012 and TC
- type
- EXPERIMENTAL
- description
- At each cycle for 4 cycles, participants received pegfilgrastim 6 mg (6 mg/0.6 mL GCSF) SC approximately 24-26 hours after receiving IV infusion of docetaxel 75 mg/m\^2 and cyclophosphamide 600 mg/m\^2 IV infusion per institute's standard of care. All participants were followed for 35 (±5) days after last study treatment or patient discontinuation and long-term safety follow-up continued for 12 months after last dose of study treatment.
- intervention Names
- Drug: Pegfilgrastim
- Drug: Docetaxel
- Drug: Cyclophosphamide
- label
- (Arm 2): Pegfilgrastim and TC
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- (Arm 1): SPI-2012 and TC
- description
- Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle
- name
- SPI-2012
- other Names
- HM10460A
- Rolontis®
- Eflapegrastim
- type
- DRUG
- arm Group Labels
- (Arm 2): Pegfilgrastim and TC
- description
- Subcutaneous injection administered on Day 2 of each cycle.
- name
- Pegfilgrastim
- other Names
- Neulasta®
- type
- DRUG
- arm Group Labels
- (Arm 1): SPI-2012 and TC
- (Arm 2): Pegfilgrastim and TC
- description
- 75mg/m\^2 IV infusion administered on Day 1 of each cycle
- name
- Docetaxel
- other Names
- Taxotere
- type
- DRUG
- arm Group Labels
- (Arm 1): SPI-2012 and TC
- (Arm 2): Pegfilgrastim and TC
- description
- 600mg/m\^2 IV infusion administered on Day 1 of each cycle
- name
- Cyclophosphamide
- other Names
- Cytoxan
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 237
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- DSN was defined as the number of days of severe neutropenia (absolute neutrophil count \[ANC\] \<0.5×10\^9 per liter \[L\]) from the first occurrence of ANC below the threshold.
- measure
- Duration of Severe Neutropenia (DSN) in Cycle 1
- time Frame
- Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
- secondary Outcomes
- description
- Time to ANC recovery was defined as the time from chemotherapy administration until the participants ANC increased to \>=1.5×10\^9/L after the expected nadir. For participants with ANC value \>=1.5×10\^9/L at all times, time to ANC Recovery was assigned a value of 0.
- measure
- Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1
- time Frame
- Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
- description
- The depth of ANC Nadir was defined as the lowest ANC value after administration of study drug (SPI-2012 or pegfilgrastim) in Cycle 1.
- measure
- Depth of ANC Nadir in Cycle 1
- time Frame
- Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
- description
- FN was defined as an oral temperature \>38.3 degree Celsius (°C) (101.0 degrees Fahrenheit \[°F\]) or two consecutive readings of \>38.0°C (100.4°F) for 2 hours and ANC \<1.0×10\^9/L.
- measure
- Number of Participants With Febrile Neutropenia (FN) in Cycle 1
- time Frame
- Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
- description
- DSN was defined as the number of days of severe neutropenia (ANC \<0.5×10\^9/L) from the first occurrence of ANC below the threshold.
- measure
- Duration of Severe Neutropenia (DSN) in Cycles 2, 3 and 4
- time Frame
- Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)
- description
- Neutropenic complications refer to hospitalizations due to neutropenic events and/or the use of anti-infectives due to neutropenia.
- measure
- Number of Participants With Neutropenic Complications in Cycle 1
- time Frame
- Day 1 and daily on Days 4-15 in Cycle 1 (each cycle = 21 days)
- description
- FN was defined as an oral temperature \>38.3°C (101.0°F) or two consecutive readings of \>38.0°C (100.4°F) for 2 hours and ANC \<1.0×10\^9/L.
- measure
- Number of Participants With Febrile Neutropenia in Cycles 2, 3 and 4
- time Frame
- Days 1, 4, 7, 10, and 15 of Cycles 2, 3, and 4 (each cycle = 21 days)
- description
- RDI was defined as the percentage of the planned dose of TC chemotherapy that each participant actually received during the study, and is expressed as the total dose received, divided by total dose planned multiplied by 100. The planned dose was defined as the dose that would be given if no doses were missed and/or no dose reductions were made for the number of cycles started. The total planned dose was the sum of planned doses over all cycles.
- measure
- Relative Dose Intensity (RDI) of TC Chemotherapy
- time Frame
- Cycles 1, 2, 3 and 4 (each cycle = 21 days)
- description
- An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product or study procedure, whether or not considered related to the medicinal product. A TEAE is any AE that occurred from the first dose of study treatment through 12 months after the last dose of study treatment or 35 (±5) days after date of participant early discontinuation. SAE is defined as any AE which meets any of the following criteria: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, includes important medical events.
- measure
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), and Death
- time Frame
- Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
- description
- The number of participants with clinically significant hematology (including basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, hematocrit, hemoglobin, lymphocytes, lymphocytes/leukocytes, monocytes, monocytes/leukocytes, neutrophils, neutrophils/leukocytes, platelets, and white blood cells) and serum chemistry (including alanine aminotransferase \[ALT\], alkaline phosphatase \[ALP\], aspartate aminotransferase \[AST\], bilirubin, calcium, cholesterol, creatinine, potassium, sodium, and triglycerides) laboratory abnormalities were reported. Clinically significant findings in laboratory parameters were based on investigator's discretion according to Common Technical Criteria for Adverse Events (CTCAE) Version 4.03.
- measure
- Number of Participants With Clinically Significant Laboratory Abnormalities
- time Frame
- Up to 4 cycles (each cycle = 21 days) plus a 12-month follow-up from the last dose (up to 15 months)
Full study description
- brief Summary
- The purpose of this study is to compare the efficacy of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) as measured by the duration of severe neutropenia (DSN).
- detailed Description
- This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 versus pegfilgrastim in participants with early-stage breast cancer treated with TC chemotherapy as measured by the duration of severe neutropenia (DSN). Each cycle was 21 days. Four cycles were evaluated for this study. On Day 1 of each cycle, participants received TC chemotherapy. On Day 2 of each cycle, participants received study drug (SPI-2012 or pegfilgrastim). After cycle 1, as applicable, participants who received at least one dose of study drug will be followed for safety for 12 months after the last dose of study treatment.
Source references
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice