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IBCSG Trial 22-00 Serum Substudy

NCT02393833 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2021-05-18

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Aron Goldhirsch, Prof. · IEO Milano

  • Giuseppe Viale, Prof. · IEO Milano

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2018-03-06
Completion
2018-03-06

Countries

  • Italy
  • Nigeria
  • Peru

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02393833 on ClinicalTrials.gov