SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide

Spectrum Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Neutropenia

Treatments: Drug: Cyclophosphamide; Drug: Pegfilgrastim; Drug: Docetaxel; Drug: SPI-2012

Study type: Interventional

Funder types: Industry

Identifiers

NCT02953340

SPI-GCF-302

2016-003469-24 (EudraCT Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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237 participants in 2 patient groups

(Arm 1): SPI-2012 and TC

Experimental group

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.

Treatment:

Drug: SPI-2012

Drug: Docetaxel

Drug: Cyclophosphamide

(Arm 2): Pegfilgrastim and TC

Experimental group

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.

Treatment:

Drug: Docetaxel

Drug: Pegfilgrastim

Drug: Cyclophosphamide