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Table 1 Ongoing clinical trials in axillary surgery [95]

From: Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (TAXIS): study protocol for a multicenter, randomized phase-III trial

 

Country/name

Population

Randomization

Endpoint

Size

Start

End

TAXIS overlap

1

Italy: SOUND IEO S637/311 NCT02167490

cT1cN0

US negative

SLN vs. observation

DDFS

1560

Jan 2012

Jan 2017

No

2

Germany: INSEMA NCT02466737

cT1–2 cN0

US negative

1. SLN vs. observation

2. 1–2 SLN+ → ALND vs. no ALND

DFS

7095

Sept 2015

Sept 2024

No

3

France: SERC/IPC 2012–001 DNCT01717131

cT1–2 cN0

ALND vs. no ALND

DFS

3000

July 2012

July 2025

Minimal

4

China: Z0011-China NCT01796444

cT1–2 cN0

1–2SLN+

ALND vs. no ALND

DFS

Not shown

Jan 2013

June 2026

No

5

Sweden: SENOMAC NCT02240472

cT1–2 cN0

cT1–2 iN1

1–2 SLN+

ALND vs. no ALND

BCSS

3500

Jan 2015

Dec 2029

Minimal

6

United Kingdom: POSNOC NCT02401685

cT1–2

1–2 SLN+

ALND or axillary radiotherapy vs. no axillary treatment

Axillary recurrence

1900

Jan 2014

Mar 2023

No

7

Netherlands: BOOG 2013–07 NCT02112682

cT1–2 cN0

1–3 SLN+

mastectomy

ALND or axillary radiotherapy vs. no axillary treatment

RRR

878

June 2014

June 2027

No

8

USA: Alliance A011202 NCT01901094

cT1-3cN1

(S)LN+ after

NACT

ALND+ extended regional nodal irradiation vs. axillary radiotherapy + extended regional nodal irradiation

IBC-RFI

2918

Feb 2014

Jan 2024

Partial

  1. ALND axillary lymph node dissection, BCSS, DFS disease-free survival, IBC, NACT, RFI, RRR, SLN sentinel lymph node, US ultrasound