Establishing the Role of Stereotactic Ablative Body Radiotherapy in Early-Stage Breast Cancer

Table 2

Ongoing phase I/II studies exploring the use of SABR in the neoadjuvant setting.

Name of study	Estimated number to be enrolled	Inclusion	Primary endpoints	SABR dose
Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer (ARTEMIS) [21]	32	Women ≥ 70 yr with preoperative early-stage breast cancer, followed by lumpectomy at 8–12 weeks after SABR	Treatment feasibility	40 Gy in 5 fractions every other day
Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer (ABLATIVE) [22]	25	Core biopsy positive nonlobular carcinoma, with negative sentinel lymph node biopsy followed by lumpectomy 6 months after SABR	Pathological complete response	20 Gy in 1 fraction
Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer [23]	100	Women ≥ 50 yr, biopsy proven, CT1N0, ER +ve, invasive ductal, or DCIS, followed by lumpectomy 8–12 weeks after SABR	Rate of pathological response at time of surgery	21 Gy in 1 fraction
Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy (SIGNAL) [24]	120	Postmenopausal women ≥ 55 yr, ≤3 cm, ER +ve, clinically node negative, invasive ductal carcinoma, followed by lumpectomy 6–8 weeks after SABR	Toxicity resulting from radiation	21 Gy in 1 fraction
Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer [25]	40	Women ≥ 50 yr, invasive adenocarcinoma, ≤2 cm, followed by lumpectomy 6 weeks after SABR	Rate of pathological complete response	3 fractions