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NCT03513614 · ClinicalTrials.gov registry record · NA
Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS)
A NA study of Node-positive Breast Cancer, sponsored by University Hospital, Basel, Switzerland.
- Recruiting
- Registry status
- NA
- Development phase
- 1,500
- Enrollment target
- 20
- Study locations
NCT03513614: Recruiting NA study of Node-positive Breast Cancer, sponsored by University Hospital, Basel, Switzerland.
NCT03513614 is a NA study of Node-positive Breast Cancer that is actively recruiting participants, run by University Hospital, Basel, Switzerland. The registered enrollment target is 1,500 participants, above the 124-participant average among 4 other Node-positive Breast Cancer trials with a reported enrollment target (1110% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03513614, a NA study of Node-positive Breast Cancer, is actively recruiting participants, sponsored by University Hospital, Basel, Switzerland.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,500 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary endpoint of this trial is DFS, defined as time from randomization until one of the following events, whichever comes first: * Local recurrence, regional recurrence, distant recurrence * Second breast cancer * Death from any cause Patients not experiencing an event will be censored at the date of the last available assessment.
Conditions Studied
Interventions
- PROCEDURE Tailored axillary surgery - both Arms
- RADIATION Radiotherapy - Arm A
- RADIATION Radiotherapy - Arm B
Study Locations (20)
Other
- Institute of Oncology "Angel H. Roffo - Buenos Aires
- Krankenhaus Dornbirn - Dornbirn
- Landeskrankenhaus Feldkirch - Feldkirch
- Medical University of Innsbruck, Department of Gynecology - Innsbruck
- Ordens Kinikum Linz, Barmherzige Schwestern - Linz
- Universitätsklinik für Frauenheilkunde und Geburtshilfe; Landeskrankenhaus Salzburg der PMU - Salzburg
- Medizinische Universität Wien - Klinik für Chirurgie - Vienna
- Medizinische Universität Wien - Universitätsklinik für Frauenheilkunde - Vienna
- Hanusch Hospital Vienna - Vienna
- Klinikum Wels-Grieskrichen GmbH - Wels
- CIUSSS du Centre Ouest-de-l'Île-de-Montréal, Jewish General Hospital - Montreal
- Breast Centre of Clinical Hospital - Rijeka
- HRUHC Sestre milosdrnice - Zagreb
- Ev. Waldkrankenhaus Spandau - Berlin
- KEM | Evang. Kliniken Essen-Mitte gGmbH - Essen
- Niels-Stensen-Kliniken Franziskus-Hospital Harderberg - Georgsmarienhütte
Maryland
- Walter Reed National Military Medical Center - Bethesda
North Carolina
- Duke University/Duke Cancer Center - Durham
Washington
- Swedish Cancer Institute - Seattle
Santa Fe Province
- Sanatorio Parque Breast Cancer Center - Rosario
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2018-08-07 |
| Est. Completion | 2036-12 |
| Phase | NA |
What NCT03513614 shows while recruiting
NCT03513614 is an interventional study that assigns participants to a tested intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, above the 124-participant average among 4 other Node-positive Breast Cancer trials with a reported enrollment target (1110% higher).
The record links to 1 condition, with Node-positive Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Tailored axillary surgery - both Arms is the first listed.
NCT03513614 names 20 study sites across 5 states, led by Other, Maryland, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03513614 about?
NCT03513614 is a clinical study titled "Tailored Axillary Surgery With or Without Axillary Lymph Node Dissection Followed by Radiotherapy in Patients With Clinically Node-positive Breast Cancer (TAXIS)". 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 whil...
What is the current status of trial NCT03513614?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,500 participants. The study started on 2018-08-07. Estimated completion is 2036-12.
What conditions does trial NCT03513614 study?
This clinical trial studies the following conditions: Node-positive Breast Cancer.
What interventions are being tested in trial NCT03513614?
The interventions under investigation include: Tailored axillary surgery - both Arms (PROCEDURE), Radiotherapy - Arm A (RADIATION), Radiotherapy - Arm B (RADIATION).
Who is sponsoring clinical trial NCT03513614?
This trial is sponsored by University Hospital, Basel, Switzerland, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03513614 being conducted?
This trial has 20 study locations across Maryland, North Carolina, Washington, Santa Fe Province. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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