A study to evaluate the Efficacy and Safety of LA-EP2006 and NeulastaÂ® in patients with breast cancer.

A randomized, double-blind, parallel-group, multi-center Phase 3 comparative study investigating efficacy and safety of LA-EP2006 and NeulastaÂ® in breast cancer patients treated with myelosuppressive chemotherapy. - PROTECT-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/09/003030

Enrollment

302

Registered

2012-09-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Prevention of neutropenic complications in breast cancer patients treated with myelosuppressive chemotherapy

Interventions

Intervention1: LA-EP2006: Therapy: LA-EP2006 6mg s.c, on Day 2 of each chemotherapy cycle. Total six TAC chemotherapy cycles. Duration: The total study duration is approximately 10 months. Control Int

Eligibility

Inclusion criteria

Inclusion criteria: 1. histologically proven breast cancer 2. eligible for six cycles of neoadjuvant or adjuvant chemotherapy

Exclusion criteria

Exclusion criteria: 1. History of cancer 2. Active infection 3. Known immunodeficiency syndrome 4. Previous therapy with any G-CSF (granulocyte-colony stimulating factor) product Other protocol-defined inclusion/exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Mean duration of Grade 4 neutropenia during Cycle 1 of chemotherapy.Timepoint: during Cycle 1 of chemotherapy.	—

Secondary

Measure	Time frame
Incidence of febrile neutropenia. Incidence, occurrence and severity of (serious) adverse events. Timepoint: across all cycles	—

Countries

India, Russian Federation

Contacts

Public ContactSanjay Kabra

PharmaNet-i3

slokaranjan@pharmanet-i3.com914040155187

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026