This is a proof-of-concept phase II trial to assess the safety (as primary endpoint) and clinical efficacy of neoadjuvant therapy with Elacestrant and PULSAR. The study will enroll 21 postmenopausal patients with early HR+ HER2- node positive BC, clinically staged II-III. Patients will receive Elacestrant 345 mg orally once daily for 24 weeks and PULSAR on the MRI-based breast gross tumor volume (GTVt), consisting of 10 Gy "pulse" every 4 weeks for a maximum of 5 or less in case of radiologic complete response. Surgery will be planned 24 weeks after Elacestrant initiation and at least 2 weeks from the last pulse and will be performed as per recommended clinical practice. Patients will then receive adjuvant systemic therapy as per standard of care and postoperative RT to the locoregional lymph nodes in case of nodal residual disease, if indicated.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting
Timeframe: Baseline, every two weeks in the pre-operative period, 30 days and 3 months after surgery
Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting
Timeframe: Baseline, every two weeks unitl week 4, then every 4 weeks in the pre-operative period, 30 days and 3 months after surgery
Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting
Timeframe: Baseline, every two weeks in the pre-operative period, 30 days, 3 months, 6 months and 12 months after surgery
Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting
Timeframe: Baseline, every two weeks until week 4 and then every 4 weeks in the pre-operative period, 30 days, 3 months, 6 months and 12 months after surgery
Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting
Timeframe: Baseline, at the beginning (week 0) and at the end (week 20) of pre-operative treatment.
Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting
Timeframe: Baseline, every two weeks until week 4 and then every 4 weeks in the pre-operative period, 30 days, 3 months, 6 months and 12 months after surgery
Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting
Timeframe: Baseline, every two weeks until week 4 and then every 4 weeks in the pre-operative period, 30 days, 3 months, 6 months and 12 months after surgery
Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting
Timeframe: Baseline, every two weeks until week 4 and then every 4 weeks in the pre-operative period, 30 days, 3 months, 6 months and 12 months after surgery
Safety of Elacestrant combined with PULSAR radiation therapy in preoperative setting
Timeframe: Baseline, every two weeks until week 4 and then every 4 weeks in the pre-operative period, 30 days, 3 months, 6 months and 12 months after surgery