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TERMINATED
NCT02393833
NA

IBCSG Trial 22-00 Serum Substudy

Sponsor: ETOP IBCSG Partners Foundation

View on ClinicalTrials.gov

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.

Official title: Assessment 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 Participating in Trial IBCSG 22-00

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

136

Start Date

2002-06

Completion Date

2018-03-06

Last Updated

2026-08-12

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Blood samples collection

Blood samples to be collected at the following time points: 1. Baseline, (after the completion of induction chemotherapy and, if randomized to CM maintenance, before start of CM maintenance.) 2. Months 12, 18 and 36 after start of induction chemotherapy 3. At time of confirmatory evidence of progression

Locations (3)

Istituto Europeo di Oncologia (IEO

Milan, Italy

Ibadan, Nigeria

Lima, Peru