Neugranin in Breast Cancer Participants Receiving Doxorubicin/Docetaxel (NEUGR-003)

Teva Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Chemotherapy-induced Neutropenia

Treatments: Biological: Pegfilgrastim; Drug: Chemotherapy; Biological: Neugranin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01126190

NEUGR-003

Details and patient eligibility

About

Determination of the effect of neugranin on the duration and severity of severe neutropenia in participants receiving doxorubicin in combination with docetaxel.

Enrollment: 381 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast cancer participants scheduled to receive the AT regimen (doxorubicin/ docetaxel)

Exclusion criteria

• Participants may have received no more than 1 prior chemotherapy regimen (including adjuvant therapy if given within the last 12 months)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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381 participants in 3 patient groups

Double-Blind Phase: Pegfilgrastim

Active Comparator group

Description:

Participants will receive pegfilgrastim 6 milligrams (mg), administered by subcutaneous (SC) injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/square meter (m\^2) and docetaxel 75 mg/m\^2 administered sequentially by intravenous (IV) infusion on Day 1 of treatment for up to four 21-day cycles.

Treatment:

Biological: Pegfilgrastim

Drug: Chemotherapy

Double-Blind Phase: Neugranin 40 mg

Experimental group

Description:

Participants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.

Treatment:

Biological: Neugranin

Drug: Chemotherapy

Open-Label Phase: Neugranin 40 mg

Experimental group

Description:

Participants will receive neugranin 40 mg, administered by SC injection once per chemotherapy cycle (approximately 24 hours after chemotherapy administration) for up to 4 cycles (each cycle length = 21 days). The chemotherapy regimen consists of doxorubicin 60 mg/m\^2 and docetaxel 75 mg/m\^2 administered sequentially by IV infusion on Day 1 of treatment for up to four 21-day cycles.

Treatment:

Biological: Neugranin

Drug: Chemotherapy