Validation of TAD in HER-2 with More Than 2 Lymph Nodes (NCT06821490) | Clinical Trial Compass
By InvitationNot Applicable
Validation of TAD in HER-2 with More Than 2 Lymph Nodes
Spain21 participantsStarted 2024-06-30
Plain-language summary
The main objective of the study is to validate the DAT technique in patients with Her2-positive breast cancer who have more than two positive axillary lymph nodes at diagnosis. After receiving adequate oncological treatment and axillary assessment by ultrasound for complete radiological response, DAT and Berg level I and II lymphadenectomy will be performed to assess false negatives and positives, as well as their sensitivity and specificity.
Who can participate
Age range
18 Years
Sex
ALL
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:
* ECOG 0-1 (physical condition: able to walk and live a normal life)
* Patients with early-stage breast cancer (BC) with histopathological diagnosis of HER2+ and axillary involvement.
Patients with either positive or negative hormonal receptor expression will be included.
* Patients must have marked the pathological axillary lymph node.
* Any number of affected or suspicious lymph nodes at diagnosis is allowed.
* Patients will receive appropriate neoadjuvant treatment based on a combination of chemotherapy and anti-HER2 therapy.
• After neoadjuvant treatment and prior to surgery, radiological response will be assessed.
* No relevant comorbidities, adequate liver and kidney function, and no contraindications to receive neoadjuvant treatment followed by surgery and radiotherapy.
Exclusion Criteria:
* Patients with inoperable breast cancer.
* Patients with a diagnosis of inflammatory breast cancer.
* Patients without a diagnostic biopsy of the suspicious lymph node or the presence of axillary conglomerate.
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.
What they're measuring
1
Location of the marked lymph node and the sentinel lymph node, and assessment after lymphadenectomy of number of true positives and negatives, sensitivity and specificity
Timeframe: From enrollment to the end of treatment at 12 months
Trial details
NCT IDNCT06821490
SponsorFundación para la Investigación del Hospital Clínico de Valencia