|
| Study | Accrual period | Single/multicenter | Population | Sample size calculation | Follow-up | N SLNB alone/ALND | Primary outcome | Secondary outcome | Randomisation method | Adjuvant treatment |
|
| ACSOG Z0011 [12] trial | 1999 to 2004 | Multicenter in USA;
115 institutions | Adult women with histologically; confirmed invasive breast cancer 5 cm or less AND;
breast conservation surgery AND;
clinically negative axilla AND;
positive metastatic SLN on frozen section, touch preparation, and H-E Stain
(micrometastasis in SLND alone-164 ALND-137) | 500 deaths needed for 90% power,
1900 patients accrual was planned,
only 891 randomised | 5.2–7.7 years;
median 6.3 years | 446/
445 | Overall Survival;
occurrence of surgical morbidities | Disease free survival | Not mentioned | All received whole breast irradiation.
Systemic therapy not specified |
|
| AATRM [15] Trial | 2001 to 2008 | Multicenter in Spain;
18 institutions | Patients with newly diagnosed breast cancer less than 3.5 cm AND;
mastectomy or breast conservation surgery AND;
clinically negative axilla AND;
SLN micrometastasis with metastatic cell deposit 0.2–2 mm (from 2002) and excluding isolated tumour cells from 2002 | 352 patients planned for accrual based on survival curves with Log Rank method
(247 recruited) | 2 to 8.9 years;
median 5.1 years | 121/
112 | Disease free Survival | | Not mentioned | All received postoperative systemic therapy.
Breast-conserving surgery received tangential breast radiation |
|
| IBCSG 23-01 [17] trial | 2001 to 2012 | Multicenter from Europe, South America, and Australia;
27 institutions | Women newly diagnosed with breast cancer 5 cm or less AND;
mastectomy or conservative surgery AND;
clinically negative axilla AND;
SLN micrometastasis including isolated tumour cells | 558 events needed for 90% power,
1960 patients planned for target accrual
(934 recruited) | 3.6 to 7.3 years;
median 5 years | 469/
465 | Disease free Survival | Overall survival;
site of recurrence;
morbidity of ALND | Permuted blocks generated by a congruence algorithm | Majority of patients in both arms received systemic therapy and radiation therapy with breast conservation |
|
