BridgeMD
New treatment option for Breast Cancer
Official title Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability
ClinicalTrials.gov ID: NCT06382818
What this study is testing
- What it's testing
- Our objective is based on a personalized approach of adjuvant breast radiotherapy by selecting patients according to tumor recurrence and toxicity risk.
- Time commitment: about 5 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- General criteria (for all cohorts):
- Women ≥ 18 years old.
- Invasive breast cancer treated by conservative or radical surgery.
- Conservative breast cancer surgery or radical mastectomy.
- Indication of breast irradiation.
You likely can't join if
- 1\. Patients with distant metastases.
- 2\. Patients with breast DCIS (ductal carcinoma in situ) 3. Concomitant bilateral breast cancer 4. Previous breast radiotherapy 5. Patients with...
- 6\. Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.
- 7\. Patients known to be HIV positive (no specific tests are required to determine the eligibility).
- 8\. Patients known as hypersensitive to radiation 9. Patients treated with systemic investigational drugs during the present study (Observational...
See the full eligibility criteria
- General criteria (for all cohorts):
- Women ≥ 18 years old.
- Invasive breast cancer treated by conservative or radical surgery.
- Conservative breast cancer surgery or radical mastectomy.
- Indication of breast irradiation.
- Extension evaluation of disease will be proven negative (M0).
- Negative pregnancy test (blood or urine at the choice of investigator), to be carried out within 7 days of registration, for women of childbearing age only.
- Effective contraception for women of childbearing age
- Must be geographically accessible for follow-up.
- Written and dated informed consent.
- Affiliated to the French national social security system. Cohort A and B: \- Low risk of recurrence (all of the criteria)
- pT1-T2
- SBR (Scarff Bloom et Richardson grade) grade ≤ 2 (low grade)
- ER+ and / or PR+ (hormone-receptor positive)
- cN0/pN-
- HER 2 -
- Ki67 ≤10% pN- with T3-4 and grade 3 and internal tumor will be considered at high risk of recurrence and will be proposed node irradiation (and will be switched to COHORT C or D). Cohort C and D: \- High risk of...
- ER- and PR-
- HER2 amplified
- pT3-4
- SBR grade ≥ 3
- KI67 \> 10% Cohort A and C:
- Low risk of breast toxicities identified by the NovaGray RILA Breast® test Cohort B and D: \- High risk of breast toxicities identified by the NovaGray RILA Breast® test
- 1\. Patients with distant metastases.
- 2\. Patients with breast DCIS (ductal carcinoma in situ) 3. Concomitant bilateral breast cancer 4. Previous breast radiotherapy 5. Patients with previous or concomitant other (not breast cancer) malignancy within the...
- 6\. Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.
- 7\. Patients known to be HIV positive (no specific tests are required to determine the eligibility).
- 8\. Patients known as hypersensitive to radiation 9. Patients treated with systemic investigational drugs during the present study (Observational cohorts are accepted if the collection of data does not interfere with...
The study team makes the final eligibility decision.
Where it's taking place
- Montpellier, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montpellier, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.