Radiotherapy After Primary Chemotherapy for Breastcancer (NCT01279304) | Clinical Trial Compass
CompletedNot Applicable
Radiotherapy After Primary Chemotherapy for Breastcancer
Netherlands851 participantsStarted 2011-01
Plain-language summary
The primary aim of the study is to evaluate the 5 yr locoregional recurrence rate (LRR) in cT1-2cN0-1(cytology/histology and/or positive SN, excluding patients with \> 3 pathologic axillary nodes on imaging) breast cancer patients, treated with neoadjuvant chemotherapy, breast surgery, and radiotherapy that is protocolized based on the pathology findings after chemotherapy and definitive surgery (ypTNM stage).
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* cT1-2 invasive breast cancer, without or with one or more pathologically proven tumour positive axillary lymph nodes (either by sentinel node biopsy, ultrasound/palpation guided biopsy or fine needle aspiration)
* At least 3 cycles of primary systemic treatment have been given (irrespective of the regimen)
* No standard axillary lymph node dissection is performed prior to chemotherapy
Exclusion criteria:
* cT3-T4 invasive breast cancer prior to any treatment
* Patients with \> 3 suspicious axillary nodes on imaging
* cN2-3 prior to any treatment
* More than focally irradical surgery and breast conserving therapy
To investigate whether a patient is eligible for the RAPCHEM study, a meticulous examination of the axilla is necessary. Therefore each patient should undergo an ultrasound of the axilla and if possible an ultrasound guided needle biopsy UNB (FNA or core). The US/UNB can be performed instantly or as second look in case of enlarged nodes on MRI. The criteria for performing an UNB are:
* Cortex \>2.3 mm not measured at the poles of the node; or
* Disappearance of the fatty hilum; or
* Asymmetric bulging of the cortex of a lymph node;
If a PET-CT is performed the worst outcome of the two studies is accepted as the real clinical stage of the axilla (i.e. 1 PA proven positive lymph node on ultrasound and 3 on PET-CT; means 3 positive lymph nodes)
The N status of the axilla prior to chemotherapy is based upon:
* Positive PET-CT of more than one…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.