Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
136 participants
INTERVENTIONAL
2002-06-30
2018-03-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Induction chemotherapy
Approved induction CT regimen after randomization
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
Induction chemotherapy followed by CM maintenance
Approved induction chemotherapy followed by 12 months of CM maintenance
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Patient must not have begun CM maintenance (if randomized to CM maintenance)
Exclusion Criteria
* Patient already begun CM maintenance (if randomized to CM maintenance)
18 Years
FEMALE
No
Sponsors
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ETOP IBCSG Partners Foundation
NETWORK
Responsible Party
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Principal Investigators
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Aron Goldhirsch, Prof.
Role: STUDY_CHAIR
IEO Milano
Giuseppe Viale, Prof.
Role: STUDY_CHAIR
IEO Milano
Locations
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Istituto Europeo di Oncologia (IEO
Milan, , Italy
Ibadan, , Nigeria
Lima, , Peru
Countries
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References
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Kern FG, Lippman ME. The role of angiogenic growth factors in breast cancer progression. Cancer Metastasis Rev. 1996 Jun;15(2):213-9. doi: 10.1007/BF00437474. No abstract available.
Gasparini G. Clinical significance of the determination of angiogenesis in human breast cancer: update of the biological background and overview of the Vicenza studies. Eur J Cancer. 1996 Dec;32A(14):2485-93. doi: 10.1016/s0959-8049(96)00376-0. No abstract available.
Revillion F, Hebbar M, Bonneterre J, Peyrat JP. Plasma c-erbB2 concentrations in relation to chemotherapy in breast cancer patients. Eur J Cancer. 1996 Feb;32A(2):231-4. doi: 10.1016/0959-8049(95)00568-4.
Byrne GJ, Ghellal A, Iddon J, Blann AD, Venizelos V, Kumar S, Howell A, Bundred NJ. Serum soluble vascular cell adhesion molecule-1: role as a surrogate marker of angiogenesis. J Natl Cancer Inst. 2000 Aug 16;92(16):1329-36. doi: 10.1093/jnci/92.16.1329.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Sponsor
Other Identifiers
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2005-005666-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IBCSG 22-00
Identifier Type: OTHER
Identifier Source: secondary_id
IBCSG 22-00 Serum Substudy
Identifier Type: -
Identifier Source: org_study_id
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