SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Breast CANCEr Patients With Docetaxel and Cyclophosphamide (ADVANCE)
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|ClinicalTrials.gov Identifier: NCT02643420|
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : March 2, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neutropenia Breast Cancer||Drug: SPI-2012 Drug: Pegfilgrastim Drug: Docetaxel Drug: Cyclophosphamide||Phase 3|
This is a Phase 3, randomized, open-label, active-controlled, multicenter study to compare the efficacy and safety of SPI-2012 (a long acting myeloid growth factor) with pegfilgrastim (Neulasta [NDC 55513-190-01] manufactured by Amgen) in breast cancer patients treated with TC chemotherapy.
Approximately 400 patients will be enrolled and randomized in a 1:1 ratio to 2 treatment arms.
Each cycle will be 21 days. Only 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 receive study drug (SPI-2012 or pegfilgrastim).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||405 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide (TC) (ADVANCE)|
|Actual Study Start Date :||April 6, 2016|
|Actual Primary Completion Date :||August 18, 2017|
|Actual Study Completion Date :||November 9, 2018|
Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle.
Other Name: Rolontis
Other Name: Taxotere
Active Comparator: Pegfilgrastim
Single-dose subcutaneous injection administered on Day 2 of each cycle.
Other Name: Neulasta®
Other Name: Taxotere
- Duration of severe neutropenia (DSN) in Cycle 1 [ Time Frame: Up to 21 days ]DSN is defined as the number of days of severe neutropenia (ANC <0.5×10^9/L) from the first occurrence of an ANC below the threshold.
- Time to Absolute Neutrophil Count (ANC) Recovery in Cycle 1 [ Time Frame: Up to 21 days ]Time to ANC Recovery is defined as the time from chemotherapy administration until the patient's ANC increases to ≥1.5×109/L after the expected nadir.
- Depth of ANC Nadir, defined as the patient's lowest ANC in Cycle 1 [ Time Frame: Up to 21 days ]Depth of ANC Nadir is defined as the lowest ANC value after administration of study drug (SPI- 2012 or pegfilgrastim) for each cycle.
- Incidence of Febrile Neutropenia (FN) in patients during Cycle 1 [ Time Frame: Up to 21 days ]Febrile neutropenia (FN) will be evaluated through daily temperature monitoring to assess for fever and frequent CBCs to assess for neutropenia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643420
|United States, Tennessee|
|The West Clinic|
|Germantown, Tennessee, United States, 38138|
|Study Director:||Zane Yang, MD||Spectrum Pharmaceuticals, Inc|