BridgeMD
New treatment option for Breast Neoplasms
Official title Single-Fraction Very Accelerated Partial Breast Irradiation (sfVAPBI)
ClinicalTrials.gov ID: NCT07067437
What this study is testing
- What it's testing
- To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older, women only
You may be able to join if
- Stage 0 \& I \& II (\< 3 cm) breast carcinoma
- Lesions of \< 3 cm diameter
- Invasive carcinoma of any subtype and grade or ductal carcinoma in situ (DCIS)
- Nodal status: node-negative (pN0) or micro-metastatic (pN1mi) (patients with pN1mi status can be treated, but due to the limited clinical evidence...
- M0: Absence of distant metastasis
You likely can't join if
- Stage III-IV breast cancer
- Surgical margins that cannot be microscopically assessed
- Extensive intraductal component (EIC+)
- Extensive lymphovascular invasion (LVI+) (focal is allowed)
- Triple negative breast cancer
- BReast CAncer gene (BRCA) 1-2 mutation
See the full eligibility criteria
- Stage 0 \& I \& II (\< 3 cm) breast carcinoma
- Lesions of \< 3 cm diameter
- Invasive carcinoma of any subtype and grade or ductal carcinoma in situ (DCIS)
- Nodal status: node-negative (pN0) or micro-metastatic (pN1mi) (patients with pN1mi status can be treated, but due to the limited clinical evidence, individual decision is needed)
- M0: Absence of distant metastasis
- Clear resection margins by National Surgical Adjuvant Breast and Bowel Project (NSABP) definition (no tumor on ink)
- Unifocal (multifocality limited within 2 cm) and unicentric breast cancer
- Age\> 40 years
- Luminal A or B tumors
- Time interval from surgery preferably less than 12 weeks and no longer than 20 weeks, and from adjuvant chemotherapy less than 4 weeks
- Human Epidermal growth factor Receptor 2 positive (HER2+) patients receiving postoperative anti-HER2 systemic therapy
- Specific signed consent form prior to randomization
- Stage III-IV breast cancer
- Surgical margins that cannot be microscopically assessed
- Extensive intraductal component (EIC+)
- Extensive lymphovascular invasion (LVI+) (focal is allowed)
- Triple negative breast cancer
- BReast CAncer gene (BRCA) 1-2 mutation
- Human Epidermal growth factor Receptor 2 positive (HER2+) patients not receiving postoperative anti-HER2 systemic therapy
- Neoadjuvant systemic therapy
- Paget's disease or pathological skin involvement
- Synchronous or previous breast cancer.
- Pregnant or lactating women
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Nancy, France
- Nice, France
- Bremerhaven, Germany
- Erlangen, Germany
- Lübeck, Germany
- Offenbach, Germany
- Würzburg, Germany
- Budapest, Hungary
- Vilnius, Lithuania
- Bialystok, Poland
- Brzozów, Poland
- Gliwice, Poland
- Poznan, Poland
- Wroclaw, Poland
- Porto, Portugal
- Kamenica, Serbia
- Barcelona, Spain
- Pamplona, Spain
- Valencia, Spain
+ 1 more site(s).
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Nancy, France; Nice, France; Bremerhaven, Germany; Erlangen, Germany; Lübeck, Germany and 15 more location(s). 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.