A two-arm, non-randomised, prospective, multicentre study using magnetic resonance imaging (MRI) findings and pathology features to select patients with early breast cancer for omission of post-operative radiotherapy (BCT 2401 PROSPECTIVE).

Full description

THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of up to 1400 participants, female >= 50 years with hstilogically confirmed ER-positive and/or HER2-positive invasive breast cancer. Participants will be selected for omission of radiation therapy (RT) (Arm A) after surgery based on having nil/minimal or mild BPE, BCS with unifocal invasive primary tumour =< 20 mm, radial resection margins must be >= 2mm clear of any invasive cancer and DCIS, pN0, absence of LVI and EIC on final pathology, and no additional BIRADs 3+ lesions. Participants who are ineligible for omission of RT, or whose clinical team determines that RT be recommended, or who choose to have RT will be allocated to standard treatment (Arm B). Arm A is further identified as: Arm A1 - Grade 1 or 2, ER positive/HER2 negative; Arm A2 - Grade 3 and/or HER2-positive. Participant recruitment will proceed until 600 participants are recruited to Arm A1. The primary endpoint is ipsilateral invasive recurrence rate (IIRR) in the breast in Arm A1 at a median of 5 years follow up (when 300th patient in Arm A1 reaches 5 years of follow up). Data set includes Cancer Australia demographic data i.e. Year of birth; postcode of home address; ATSI status, CALD status (country of birth; main language spoken as a child; main language other than English). Patient reported outcome data will be available from 192 English-speaking participants in each arm (total: 384) from PROMs measuring Fear of Cancer Recurrence (FCRI-SF); Health related QoL (BCTOS and EORTC IL353); QALYs (EQ-5D-5L), anxiety and depression (GAD-2, PHQ-2), Decision Regret Scale, Risk perception and appraisal, Neuroticism (IPIP-Neur), Experience and impact of treatment, Endocrine therapy adherence (FACT-ES + 3 additional questions).

Notes

HeSANDA 1.0.0