Clinical trial · Interventional
IBCSG Trial 22-00 Serum Substudy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sufficient statistical power cannot be met due to low samples size
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Induction chemotherapy
- description
- Approved induction CT regimen after randomization
- interventionNames
- Procedure: Blood samples collection
- type
- EXPERIMENTAL
- label
- Induction chemotherapy followed by CM maintenance
- description
- Approved induction chemotherapy followed by 12 months of CM maintenance
- interventionNames
- Procedure: Blood samples collection
Primary outcomes (3)
- measure
- Change from baseline to 18 months in serum VEGF values
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (4)
- BACKGROUNDKern 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. PMID 8842493
- BACKGROUNDGasparini 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. PMID 9059337
- BACKGROUNDRevillion 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. PMID 8664033
- BACKGROUNDByrne 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. PMID 10944555