Five-Fraction Ablative RT + Endocrine Therapy Achieves 53% pCR, Skips Surgery in Stage I HR+ Breast Cancer
- Trial ID
- NCT02945579 on ClinicalTrials.gov
- Cancer type
- Breast Cancer
- Published in
- New in Oncology - June 27, 2025
A single-arm Phase II trial (NCT02945579) enrolled 20 women ≥ 50 y with unicentric, stage I HR+/HER2- tumors (Oncotype ≤25). After three months of endocrine therapy and hypofractionated ablative radiotherapy (37.5 Gy/5 fx, every other day), vacuum-assisted biopsies at 6–12 mo showed pathologic CR in 10/19 (52.6%) and near-CR in another 7/19 (36.8%); pCR rate rose from 45% at 6 mo to 63% at 12 mo. Only 7 patients required surgery, and among the 12 who avoided it, no local recurrences have emerged at a median 26 mo. By contrast, neoadjuvant endocrine therapy alone rarely tops 10% pCR in ER+ disease, underscoring the boost from ablative RT.
Take home
Early data hint that endocrine + ultra-short RT could let carefully selected low-risk HR+ patients skip the knife, but the tiny cohort and short follow-up mean definitive trials—and vigilant long-term surveillance—are essential before practice changes.
More on NCT02945579
More in breast cancer
-
Trial result · Oct 22, 2026 · NCT02364557
NRG-BR002: Metastasis-directed ablation (SBRT/surgery) fails to extend PFS in oligometastatic breast cancer on 1L systemic therapy -
Trial result · Oct 22, 2026 · NCT05963984
Samuraciclib + fulvestrant shows higher clinical benefit and numerically longer PFS after CDK4/6 inhibition in randomized Phase 2 breast cancer trial -
Trial result · Oct 15, 2026 · NCT05306340
Giredestrant (oral SERD) + everolimus improves PFS after CDK4/6 inhibition, with the strongest benefit in ESR1-mutated breast cancer -
Trial result · Oct 15, 2026 · NCT02264678
Ceralasertib (ATR inhibitor) + Olaparib (PARP inhibitor) hits 37.8% ORR in PARPi‑naïve BRCA‑mut HER2‑neg breast cancer -
New trial · Oct 15, 2026 · NCT07844759
Pilot study tests single-fraction stereotactic radiation plus endocrine therapy without lumpectomy in early breast cancer
