## Protocol Section
### Identification Module
**NCT ID:** NCT06418126

**Acronym:** TNBC-RT2023

**Brief Title:** Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer

**Official Title:** Prediction of Radiotherapy Efficacy in Patients With Triple-negative Breast Cancer : TNBC-RT2023

#### Organization Study ID Info
**ID:** 2023-003
#### Organization
**Class:** OTHER
**Full Name:** Institut de cancérologie Strasbourg Europe
### Status Module
#### Completion Date
**Date:** 2027-04-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-04-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-11

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-11
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Centre de recherche du Centre hospitalier universitaire de Sherbrooke

#### Lead Sponsor

**Class:** OTHER

**Name:** Institut de cancérologie Strasbourg Europe

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Recurrence of triple-negative breast cancer (TNBC) occurs in around 30% of patients within 3 years of treatment. For some TNBC patients, recurrence occurs on average 2.6 years after treatment, while for others recurrence does not occur early. TNBC patients can therefore be divided into two groups: those with early recurrence and those who respond well to treatment.

At present, there are no biomarkers to differentiate these two groups. Some studies suggest that radiation-induced inflammatory cytokines may stimulate the development of new metastases. Gene expression profiling or protein signatures have not been able to define such biomarkers.

The aim of this research protocol is to recruit patients to evaluate if the elevation of the cytokines IL-1β, IL-5 and IL-6 in plasma collected during radiotherapy can be used to predict TNBC patients at high risk of recurrence.

### Conditions Module

**Conditions:**

- Triple-negative Breast Cancer

**Keywords:**

- Radiotherapy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 15

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will be recruited before the start of radiotherapy. A blood sample (20 ml) will be taken before radiotherapy and immediately after the 4th radiotherapy session.

They will be followed up annually for 5 years after the end of treatment, to determine whether their cancer has recurred.

**Intervention Names:**

- Biological: blood sampling before radiotherapy

- Biological: blood sampling after the fourth radiotherapy session

- Other: collection of acute toxicity (radiodermatitis)

- Other: collection of late toxicity

- Other: collection of disease status

- Radiation: Radiotherapy - Breast +/- lymph node areas

- Radiation: Radiotherapy - Boost operating bed

**Label:** Women with TNBC breast cancer

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Women with TNBC breast cancer

**Description:** A blood sample (20 ml) will be taken prior to radiotherapy

**Name:** blood sampling before radiotherapy

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Women with TNBC breast cancer

**Description:** A blood sample (20 ml) will be taken immediately after the 4th radiotherapy session.

**Name:** blood sampling after the fourth radiotherapy session

**Type:** BIOLOGICAL

#### Intervention 3

**Arm Group Labels:**

- Women with TNBC breast cancer

**Description:** for the entire duration of radiotherapy

**Name:** collection of acute toxicity (radiodermatitis)

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Women with TNBC breast cancer

**Description:** every year for 5 years

**Name:** collection of late toxicity

**Type:** OTHER

#### Intervention 5

**Arm Group Labels:**

- Women with TNBC breast cancer

**Description:** throughout the study

**Name:** collection of disease status

**Type:** OTHER

#### Intervention 6

**Arm Group Labels:**

- Women with TNBC breast cancer

**Description:** 40.05 Gy in 15 fractions of 2.67 Gy, one fraction per week, 5 days per week Or 50 Gy in 25 fractions of 2 Gy, one fraction per week, 5 days per week

**Name:** Radiotherapy - Breast +/- lymph node areas

**Type:** RADIATION

#### Intervention 7

**Arm Group Labels:**

- Women with TNBC breast cancer

**Description:** 10 Gy in 4 fractions of 2.5 Gy, one fraction per week, 5 days per week Or 16 Gy in 8 fractions of 2 Gy, one fraction per week, 5 days per week

**Name:** Radiotherapy - Boost operating bed

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Description:** Determine whether TNBC patients who respond poorly to radiotherapy can be identified by the appearance of inflammatory cytokines in the blood during radiotherapy.

**Measure:** Predictive value of recurrence associated with the appearance of inflammatory cytokines

**Time Frame:** up to 5 years

#### Secondary Outcomes

**Description:** TNBC cells will be incubated with plasma collected before or during radiotherapy. Boyden chambers will be used to determine the increase in cell invasion.

**Measure:** To determine whether the increased invasive capacity of TNBC cells incubated with plasma collected during radiotherapy will be associated with recurrence.

**Time Frame:** up to 5 years

**Description:** Number and sizes of metastases to the lungs will be determined after i.v. plasma injection in Balb/c mice.

**Measure:** To determine whether the development of metastases in a mouse model injected with TNBC D2A1 cells pre-incubated with plasma collected during radiotherapy will be associated with recurrence.

**Time Frame:** up to 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Women with TNBC breast cancer who meet the following criteria:

* Women aged 18 and over;
* Any tumor size (pT stage);
* Regional lymph node pN0 to pN3;
* Patient with pathologically confirmed TNBC (estrogen and progesterone receptor negative and HER2 negative);
* Neo- or adjuvant chemotherapy followed by radiotherapy;
* No evidence of distant metastasis at time of diagnosis;
* Primary tumor removed by conservative surgery with negative margins;
* Patient covered by the French social security system (for French patients).

Exclusion Criteria:

* Distant metastasis at the time of diagnosis;
* Pregnant or breast-feeding women;
* Woman deprived of liberty, under guardianship or trusteeship.
* Patient unable to give consent
* Patient unable to speak French
* Patients unable to undergo regular long-term surveillance.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** v.sartori@icans.eu

**Name:** Valérie SARTORI

**Phone:** 0368767223

**Phone Ext:** 33

**Role:** CONTACT

**Contact 2:**

**Email:** promotion-rc@icans.eu

**Name:** Manon VOEGELIN

**Phone:** 0368767360

**Phone Ext:** 33

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Strasbourg

**Contacts:**

***Contact 1:***

- **Email:** v.sartori@icans.eu

- **Name:** Valérie SARTORI

- **Phone:** 0368767223

- **Phone Ext:** 33

- **Role:** CONTACT

***Contact 2:***

- **Email:** promotion-rc@icans.eu

- **Name:** Manon VOEGELIN

- **Phone:** 0368767360

- **Phone Ext:** 33

- **Role:** CONTACT

***Contact 3:***

- **Name:** Georges NOEL

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** Institut de cancérologie Strasbourg europe

**Status:** RECRUITING

**Zip:** 67033

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M30373

- Name: Triple Negative Breast Neoplasms

- Relevance: HIGH

- As Found: Triple Negative Breast Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000064726

- Term: Triple Negative Breast Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
