Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments cyclophosphamide, doxorubicin hydrochloride, epirubicin hydrochloride, fluorouracil, methotrexate, adjuvant therapy, docetaxel, paclitaxel
Phase phase 3
Sponsor International Breast Cancer Study Group
Start date June 2002
End date December 2019
Trial size 136 participants
Trial identifier NCT02393833, 2005-005666-36, IBCSG 22-00, IBCSG 22-00 Serum Substudy

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
Approved induction CT regimen after randomization
cyclophosphamide
doxorubicin hydrochloride
epirubicin hydrochloride
fluorouracil
methotrexate
adjuvant therapy
docetaxel
paclitaxel
(Experimental)
Approved induction chemotherapy followed by 12 months of CM maintenance
cyclophosphamide
doxorubicin hydrochloride
epirubicin hydrochloride
fluorouracil
methotrexate
adjuvant therapy
docetaxel
paclitaxel

Primary Outcomes

Measure
Change from baseline to 18 months in serum VEGF values
time frame: 18 months
Change from baseline to 18 months in serum VCAM-1 values
time frame: 18 months
Change from baseline to 18 months in serum NRP values
time frame: 18 months

Secondary Outcomes

Measure
Change from baseline to 12 and 36 months in serum VEGF values
time frame: 12 & 36 months
Change from baseline to 12 and 36 months in serum VCAM-1 values
time frame: 12 & 36 months
Change from baseline to 12 and 36 months in serum NRP values
time frame: 12 & 36 months
Change in serum VEGF values from last measurement before progression to measurement at time of confirmatory evidence of progression
time frame: Baseline,12-, 18- or 36-months & progression
Change in serum VCAM-1 values from last measurement before progression to measurement at time of confirmatory evidence of progression
time frame: Baseline,12-, 18- or 36-months & progression
Change in serum NRP values from last measurement before progression to measurement at time of confirmatory evidence of progression
time frame: Baseline,12-, 18- or 36-months & progression

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

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
Description The Serum Substudy 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 patients' serum samples at different time points. VEGF: Angiogenesis plays a central role in tumor progression of solid neoplasia. The switch from the avascular to the vascular phase is generally accompanied by rapid primary tumor growth and local invasiveness. Furthermore, angiogenesis is also necessary both at the beginning and end of the development of distant metastasis and is implicated in the phenomenon of dormant micrometastases. Antiangiogenic peptides may be altered in the serum or urine of cancer patients. In a study of 144 breast cancer patients, angiogenic protein basic fibroblast growth factor was abnormally elevated in the urine in 29% of cases and in the serum in 10%. Another angiogenic protein, vascular endothelial factor (VEGF), was abnormally elevated in the serum in over 70% of these breast cancer patients (4). Since platelets bind VEGF, platelet values will also be assayed. HER2-ECD: No data are available regarding the presence of serum HER2-ECD (NRP) levels in c-erbB2 negative tumors, but the extracellular domain of the c-erbB2 oncogene product (NRP) is detectable in sera of 30-60% of patients with cerbB2 positive tumors. Many reports have correlated the elevated serum levels of the cerbB2 with gene amplification and c-erbB2 overexpression in tumor. These data support the hypothesis that the level of NRP protein can reflect the presence of c-erbB2 positive cells and that modification of the factor can predict a decrease of c-erbB2 positive cells during standard adjuvant chemotherapy. Moreover, change in the detectable NRP during the maintenance phase can suggest a possible modification in the biology and/or behaviour of hypothetic micrometastasis. VCAM-1: In tumors, endothelial VCAM-1 play a major role in the adhesion of leukocytes to the endothelium, suggesting a relationship between cellular adhesion and angiogenesis. Soluble VCAM-1 has been implicated in the mediation of angiogenesis and some studies support the hypothesis that VCAM-1 provides surrogate markers for endothelial activation and angiogenesis occurring during cancers. Recently, VCAM-1 serum levels have been associated with microvessel density and response to endocrine therapy.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by International Breast Cancer Study Group.