Serum Protein Research Substudy

• Status: Active, not recruiting
• Trial end date: 0000-00-00
• Target enrollment: 136
• Participant gender: Female

Summary

The serum protein research study is a substudy of the core study 'Maintenance Chemotherapy in Hormone Non-responsive Breast Cancer'. This substudy is an evaluation of blood proteins and their relationship to breast cancer treatment. It will assess the levels of Vascular Endothelial Growth Factor (VEGF), Soluble HER2 Protein (NRP, neu-related protein) and Vascular Cellular Adhesion Molecule-1 (VCAM-1) in serum samples of patients' blood at different time points. The goal is to evaluate differences in serum levels between patients receiving the maintenance chemotherapy and those who do not. The serum levels will be also examined to determine if they vary during the three year period of evaluation. In addition, the serum levels of patients who have a recurrence of their breast cancer will be compared with those who remain disease free. The information obtained from these studies will enable breast cancer physicians to better tailor therapies for future patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Breast Cancer Study Group
• Treatments: Cyclophosphamide; Doxorubicin; Endothelial Growth Factors; Epirubicin; Fluorouracil; Liposomal doxorubicin; Methotrexate
• Last Updated: 2016-04-12

Criteria

Inclusion Criteria:

• Patient must be randomized to the core protocol. Written informed consent for the serum substudy must be signed and dated by the patient and investigator

• Patient must not have begun CM maintenance (if randomized to CM maintenance)

Exclusion Criteria:

• Patient not randomized to the core protocol

• Patient already begun CM maintenance (if randomized to CM maintenance)