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

Clinica Luganese Moncucco

Status: Completed

Conditions: Breast Cancer

Treatments: Other: blood samples collection

Study type: Observational

Funder types: Other

Identifiers

NCT04002570

CirculatingCellsBreast-RT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

13 participants in 3 patient groups

GROUP I/GROUP I bis

Description:

20 breast cancer patients who performed radiotherapy treatment

Treatment:

Other: blood samples collection

GROUP II

Description:

maximum 10 patients who performed radiotherapy and chemotherapy and/or immunotherapy and/or neo-adjuvant hormone therapy or/and adjuvant immunotherapy/hormone therapy.

Treatment:

Other: blood samples collection

CONTROLS GROUP

Description:

healthy women with +/- 5 years compared to breast cancer patients age

Treatment:

Other: blood samples collection