Pegfilgrastim as Support to Advanced Breast Cancer Patients Receiving Chemotherapy

Amgen

Status and phase: Completed; Phase 3

Conditions: Neutropenia

Treatments: Drug: pegfilgrastim

Study type: Interventional

Funder types: Industry

Identifiers

NCT00035594

20010144

Details and patient eligibility

About

Physicians are conducting a clinical trial for patients with advanced breast cancer. Breast cancer can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in patients with advanced breast cancer.

Sex

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Advanced breast cancer
• 18 years of age or older
• Patients who will be receiving Taxotere (docetaxel) chemotherapy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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928 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Breast cancer patients receiving docetaxel chemotherapy and placebo.

Treatment:

Drug: pegfilgrastim

Pegfilgrastim

Experimental group

Description:

Breast cancer patients receiving docetaxel chemotherapy and pegfilgrastim.

Treatment:

Drug: pegfilgrastim