NCT05993559 - Necessity of Post-mastectomy Radiotherapy After Neoadjuvant Chemotherapy and Mastectomy | Biotech Hunter

Enrollment

1,314

Participants

Timeline

Start Date

November 11, 2024

Primary Completion Date

April 10, 2031

Study Completion Date

July 10, 2031

Conditions

Breast Cancer

Interventions

RADIATION

Arm I (No PMRT)

The purpose of this study is to confirm that in patients with breast cancer who have undergone mastectomy after prior neoadjuvant chemotherapy, omitting radiotherapy is non-inferior to post-mastectomy radiotherapy (PMRT) in terms of 5-year disease-free survival (DFS) in patients with pathologic complete remission and a good response to treatment corresponding to RCB class 0-I, compared to patients treated with PMRT.

RADIATION

Arm II (PMRT)

The purpose of this study is to confirm that in patients with breast cancer who have undergone mastectomy after prior neoadjuvant chemotherapy, omitting radiotherapy is non-inferior to post-mastectomy radiotherapy (PMRT) in terms of 5-year disease-free survival (DFS) in patients with pathologic complete remission and a good response to treatment corresponding to RCB class 0-I, compared to patients treated with PMRT.