Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adjuvant Radiotherapy on Circulating Cells in Breast Cancer Patients (CCB-RT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002570
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : July 14, 2020
Sponsor:
Collaborators:
Curzio Rüegg, MD, Head of Department, University of Fribourg
Swiss National Science Foundation
Tsoutsou Pelagia MD, Head of Radation Therapy Department
Information provided by (Responsible Party):
Alessandra Franzetti Pellanda, Clinica Luganese Moncucco

Brief Summary:
Radiation applied to the preserved breast during radiotherapy treatment activates numerous molecular cascades in tumor bed adjacent cells causing an inflammatory state. During this process, pre-clinical studies demonstrated CD11b + and CD11b+cKit+cells mobilization in the blood. These cells are involved in numerous processes during tumor progression/control and metastases development. The expected results in clinical setting allow us to investigate the development of innovative therapeutic and monitoring strategies. The clinical repercussions would consist in identifying new predictive and prognostic targets in breast cancer.

Condition or disease Intervention/treatment
Breast Cancer Other: blood samples collection

Detailed Description:

Every year, around one million women are newly diagnosed with breast cancer. Early screening and adjuvant treatments with curative intent such as radiotherapy, hormone therapy, chemotherapy, immunotherapy, have reduced the incidence of breast cancer specific mortality. Despite this, breast cancer remains the main cause of cancer mortality in Europe. The primary cause is due to metastases development in different organs, such as lung, liver, bones and brain. A significant decrease in mortality in breast cancer patients is likely to be achieved by preventing the formation of metastases or by implementing the efficacy of their treatment. Radiotherapy is one of the pillars of breast cancer adjuvant treatments with important survival benefits.

Mutual and dynamic communications between tumor cells and the tumor microenvironment (TME) influence the development and evolution of the tumor as well as the appearance of distant metastases. The mediators of the immune and inflammatory response that constitute TME, as well as mediators of tumor progression, are also considered "targets" of future therapeutic strategies.

Radiation applied to the preserved breast during radiotherapy treatment activates numerous molecular cascades in tumor bed adjacent cells causing an inflammatory state. During this process, pre-clinical studies demonstrated CD11b + and CD11b+cKit+cells mobilization in the blood. These cells are involved in numerous processes during tumor progression/control and metastases development. The results allow us to investigate the development of innovative therapeutic and monitoring strategies. The clinical repercussions would consist in identifying new predictive and prognostic targets in breast cancer.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effects of Adjuvant Radiotherapy on Bone-marrow Derived and Immune Cells in Breast Cancer Patients
Actual Study Start Date : October 25, 2015
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
GROUP I/GROUP I bis
20 breast cancer patients who performed radiotherapy treatment
Other: blood samples collection
blood samples collection are performed at 4 different timepoints: preop, pre rt, week 6 rt, week 12-14 (fu) for GROUP I and GROUP II; blood samples collection are performed at 3 different timepoints: pre rt, week 6 rt, week 12-14 (fu) for GROUP I bis; blood samples collection are performed just once for control GROUP.

GROUP II
maximum 10 patients who performed radiotherapy and chemotherapy and/or immunotherapy and/or neo-adjuvant hormone therapy or/and adjuvant immunotherapy/hormone therapy.
Other: blood samples collection
blood samples collection are performed at 4 different timepoints: preop, pre rt, week 6 rt, week 12-14 (fu) for GROUP I and GROUP II; blood samples collection are performed at 3 different timepoints: pre rt, week 6 rt, week 12-14 (fu) for GROUP I bis; blood samples collection are performed just once for control GROUP.

CONTROLS GROUP
healthy women with +/- 5 years compared to breast cancer patients age
Other: blood samples collection
blood samples collection are performed at 4 different timepoints: preop, pre rt, week 6 rt, week 12-14 (fu) for GROUP I and GROUP II; blood samples collection are performed at 3 different timepoints: pre rt, week 6 rt, week 12-14 (fu) for GROUP I bis; blood samples collection are performed just once for control GROUP.




Primary Outcome Measures :
  1. the frequency of CD11b⁺cKit⁺ cells in peripheral blood and/or gene expression in circulating CD11b⁺ cells [ Time Frame: pre surgery ]
    validate the hypothesis that adjuvant radiotherapy in breast cancer modulates the frequency of CD11b⁺cKit⁺ cells in peripheral blood and / or gene expression in circulating CD11b⁺ cells, evaluating their trend at different time points compared to radiotherapy treatment.

  2. the frequency of CD11b⁺cKit⁺ cells in peripheral blood and/or gene expression in circulating CD11b⁺ cells [ Time Frame: pre radiotherapy ]
    validate the hypothesis that adjuvant radiotherapy in breast cancer modulates the frequency of CD11b⁺cKit⁺ cells in peripheral blood and / or gene expression in circulating CD11b⁺ cells, evaluating their trend at different time points compared to radiotherapy treatment.

  3. the frequency of CD11b⁺cKit⁺ cells in peripheral blood and/or gene expression in circulating CD11b⁺ cells [ Time Frame: week 6 of radiotherapy ]
    validate the hypothesis that adjuvant radiotherapy in breast cancer modulates the frequency of CD11b⁺cKit⁺ cells in peripheral blood and / or gene expression in circulating CD11b⁺ cells, evaluating their trend at different time points compared to radiotherapy treatment.


Secondary Outcome Measures :
  1. radiotherapy alters in a potentially predictive way the frequency of CD11b⁺cKit⁺ cells in peripheral blood [ Time Frame: week 12-14 (fu) ]
    validate the hypothesis that adjuvant radiotherapy alters in a potentially predictive way the frequency of CD11b⁺cKit⁺ cells in peripheral blood and / or gene expression in circulating CD11b⁺ cells.


Biospecimen Retention:   Samples With DNA
blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Sampling Method:   Non-Probability Sample
Study Population
patients performing treatments for breast cancer
Criteria

Inclusion Criteria:

  • breast cancer diagnosis bioptically proven with pre-operative clinical stage cT1-4, N0-1, M0;
  • patients who are candidates for conservative surgery (tumorectomy / quadrantectomy +/- lymphadenectomy or sentinel lymph node) or patients already undergoing conservative surgery;
  • patients who are candidates for an adjuvant mammary radiotherapy treatment +/- adjuvant or neoadjuvant chemotherapy due to a triple negative or a high ki67 value that has indicated it;
  • understanding of the Italian language for the Coordinating Center, understanding of the French language for the satellite center.

Exclusion Criteria:

  • previous mastectomy surgery;
  • concomitant cancer diseases;
  • previous chemo / radiotherapy treatments in the last three years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002570


Contacts
Layout table for location contacts
Contact: Alessandra Franzetti Pellanda, MD 0041919608131 alessandra.franzetti-pellanda@moncucco.ch
Contact: Maira Biggiogero, PhDBSc 0041919608666 maira.biggiogero@moncucco.ch

Locations
Layout table for location information
Switzerland
Clinica Luganese Moncucco Recruiting
Lugano, Ticino, Switzerland, 6900
Contact: Maira Biggiogero, PhD BSc    0041 091 960 8666    maira.biggiogero@moncucco.ch   
Contact: Alessandra Franzetti Pellanda, MD    0041 091 960 8134    alessandra.franzetti-pellanda@moncucco.ch   
Principal Investigator: Alessandra Franzetti Pellanda, MD         
Sponsors and Collaborators
Clinica Luganese Moncucco
Curzio Rüegg, MD, Head of Department, University of Fribourg
Swiss National Science Foundation
Tsoutsou Pelagia MD, Head of Radation Therapy Department
Investigators
Layout table for investigator information
Principal Investigator: Alessandra Franzetti Pellanda, MD Clinica Luganese Moncucco
Publications:

Layout table for additonal information
Responsible Party: Alessandra Franzetti Pellanda, Head of Radiation Therapy, Clinica Luganese Moncucco
ClinicalTrials.gov Identifier: NCT04002570    
Other Study ID Numbers: CirculatingCellsBreast-RT
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessandra Franzetti Pellanda, Clinica Luganese Moncucco:
breast cancer
circulating bone marrow-derived cells
circulating immune cells
radiotherapy
conservative treatment
disease control
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases