Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy… (NCT03513614) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS)
United States, Argentina, Austria1,500 participantsStarted 2018-08-07
Plain-language summary
RATIONALE: The use of tailored axillary dissection as a tailored procedure will avoid surgical overtreatment by selectively removing the lymph nodes that are affected by the cancer, thereby sparing many women the unnecessary complications of a radical surgery, providing a better quality of life while keeping the same efficacy.
PURPOSE: The phase III trial is evaluating the optimal treatment for breast cancer patients in terms of surgery and radiotherapy.
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:
Inclusion criteria at pre-registration:
* Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
* Breast cancer, node positive detected by palpation or imaging (with or without planned neoadjuvant treatment)
* Female or male aged ≥ 18 years
* Ability to complete the Quality of Life questionnaires
Inclusion criteria at registration:
* Node-positive breast cancer (histologically or cytologically proven both in primary tumor and in lymph node) AJCC/UICC \[42\] stage II-III (all molecular subtypes allowed):
* Node-positivity detected by imaging (iN+) and confirmed by pathology
* Node-positivity detected by palpation (cN1-3) and confirmed by pathology
* Occult breast cancer is allowed, if biopsy-proven axillary lymphatic metastasis is present
* Eligible for primary ALND or sentinel lymph node (SLN) procedure with frozen section and either:
* Newly diagnosed
* Isolated in-breast recurrence or second ipsilateral breast cancer after previous breast conserving surgery and sentinel procedure and at least 3 years disease free and no prior axillary dissection or axillary RT
* Most suspicious axillary lymph node clipped
* Baseline Quality of Life questionnaire has been completed
* WHO performance status 0-2
* Adequate condition for general anesthesia and breast cancer surgery
* Women with child-bearing potential are using effective contraception, are not pregnant or lactating and agree not to become pregnant d…
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
Disease-free survival (DFS)
Timeframe: at the occurrence of the event or latest 20 years after randomization of the last patient