NCT02393833

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2002

Longer than P75 for not_applicable breast-cancer

Geographic Reach
3 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
11.8 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2014

Completed
1 year until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2018

Completed
Last Updated

May 18, 2021

Status Verified

May 1, 2021

Enrollment Period

15.8 years

First QC Date

March 12, 2014

Last Update Submit

May 17, 2021

Conditions

Breast Cancer

Keywords

Vascular endothelial growth factor (VEGF)Vascular cell adhesion molecule-1 (VCAM-1)HER2-ECD

Outcome Measures

Primary Outcomes (3)

  • Change from baseline to 18 months in serum VEGF values

    To evaluate differences from baseline (after completion of induction chemotherapy but before commencement of CM Maintenance for patients randomized to CM Maintenance) to 18 months after the start of induction chemotherapy in serum VEGF values between patients in the Observation Group and those in the low dose Cyclophosphamide Methotrexate (CM) Maintenance Group.

    18 months

  • Change from baseline to 18 months in serum VCAM-1 values

    To evaluate differences from baseline (after completion of induction chemotherapy but before commencement of CM Maintenance for patients randomized to CM Maintenance) to 18 months after the start of induction chemotherapy in serum VCAM-1 values between patients in the Observation Group and those in the low dose Cyclophosphamide Methotrexate (CM) Maintenance Group.

    18 months

  • Change from baseline to 18 months in serum NRP values

    To evaluate differences from baseline (after completion of induction chemotherapy but before commencement of CM Maintenance for patients randomized to CM Maintenance) to 18 months after the start of induction chemotherapy in serum NRP values between patients in the Observation Group and those in the low dose Cyclophosphamide Methotrexate (CM) Maintenance Group.

    18 months

Secondary Outcomes (6)

  • Change from baseline to 12 and 36 months in serum VEGF values

    12 & 36 months

  • Change from baseline to 12 and 36 months in serum VCAM-1 values

    12 & 36 months

  • Change from baseline to 12 and 36 months in serum NRP values

    12 & 36 months

  • Change in serum VEGF values from last measurement before progression to measurement at time of confirmatory evidence of progression

    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

    Baseline,12-, 18- or 36-months & progression

  • +1 more secondary outcomes

Study Arms (2)

Induction chemotherapy

ACTIVE COMPARATOR

Approved induction CT regimen after randomization

Procedure: Blood samples collection

Induction chemotherapy followed by CM maintenance

EXPERIMENTAL

Approved induction chemotherapy followed by 12 months of CM maintenance

Procedure: Blood samples collection

Interventions

Blood samples collectionPROCEDURE

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 chemotherapyInduction chemotherapy followed by CM maintenance

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Patient not randomized to the core protocol
  • Patient already begun CM maintenance (if randomized to CM maintenance)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Istituto Europeo di Oncologia (IEO

Milan, Italy

Location

Unknown Facility

Ibadan, Nigeria

Location

Unknown Facility

Lima, Peru

Location

Related Publications (4)

  • 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.

    PMID: 8842493BACKGROUND

  • 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.

    PMID: 9059337BACKGROUND

  • 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.

    PMID: 8664033BACKGROUND

  • 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.

    PMID: 10944555BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Aron Goldhirsch, Prof.

    IEO Milano

    STUDY CHAIR

  • Giuseppe Viale, Prof.

    IEO Milano

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 19, 2015

Study Start

June 1, 2002

Primary Completion

March 6, 2018

Study Completion

March 6, 2018

Last Updated

May 18, 2021

Record last verified: 2021-05

Locations

PE(1)IT(1)NG(1)