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New treatment option for Breast Cancer
Official title Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer
ClinicalTrials.gov ID: NCT06362616
What this study is testing
- What it's testing
- This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 51 and older, women only
You may be able to join if
- Female patients ≥ 51 years
- Ipsilateral breast cancer; recurrence or second primary
- Either histologically proven invasive adenocarcinoma (invasive adenocarcinoma with DCIS component is also accepted) or DCIS alone (calcification...
- Histologically proven estrogen receptor positive
- HER2neu negative
You likely can't join if
- ≥ grade 3 radiotherapy toxicity in the breast after treatment of the primary tumor
- Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies outside of the original boost area
- Distant metastases and/or synchronous contralateral invasive or in situ carcinoma
- Invasive lobular carcinoma (ILC) or pleiomorphic lobular carcinoma in situ (LCIS)
- ER negative subtype
- Lymphovascular invasion in biopsy
See the full eligibility criteria
- Female patients ≥ 51 years
- Ipsilateral breast cancer; recurrence or second primary
- Either histologically proven invasive adenocarcinoma (invasive adenocarcinoma with DCIS component is also accepted) or DCIS alone (calcification associated on imaging)
- Histologically proven estrogen receptor positive
- HER2neu negative
- In case of invasive adenocarcinoma: tumor size ≤ 3 cm. In case of DCIS alone: affected area ≤ 2.5 cm
- Grade I or grade II (biopsy)
- cN0M0 (No evidence of nodal or distant metastases on axillary ultrasound and, if indicated, positron emission tomography-computed tomography (PET-CT) scan)
- Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision)
- Interval since completion of local treatment of primary tumor \> 12 months
- Previous radiotherapy (whole breast or partial) of the ipsilateral breast
- Repeat breast conserving surgery feasible
- World Health Organization (WHO) performance ≤ 2
- Written informed consent
- The patient is legally competent
- ≥ grade 3 radiotherapy toxicity in the breast after treatment of the primary tumor
- Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies outside of the original boost area
- Distant metastases and/or synchronous contralateral invasive or in situ carcinoma
- Invasive lobular carcinoma (ILC) or pleiomorphic lobular carcinoma in situ (LCIS)
- ER negative subtype
- Lymphovascular invasion in biopsy
- Neoadjuvant systemic treatment for the protocol tumor (except for pre-surgery hormonal therapy ≤ 2 months)
- (Planned) oncoplastic surgery with major tissue displacement
- Participation in another clinical trial that interferes with the locoregional treatment of this protocol.
- It is expected that dosimetric constraints cannot be met, such as lung/heart constraints.
- Patients with proven BRCA-mutations
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam, Netherlands
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, 51 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam, Netherlands. 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.