A randomised phase III trial of adjuvant radiation therapy versus observation following breast conserving surgery and endocrine therapy in patients with molecularly characterised luminal A early breast cancer (ANZ 1601/BIG 16-02: EXPERT).

Full description

THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of around 1000 luminal A early breast cancer patients in a randomised phase III trial. Female patients aged >= 50 years, histologically confirmed invasive breast carcinoma <= 2 cm, grade 1 or 2, ER/PR positive, HER2 negative, primary tumour characterised by Prosigna (PAM50) assay as Luminal A intrinsic subtype and risk of recurrence score <= 60. Treated by breast conserving surgery with negative margins for invasive carcinoma and any associated ductal carcinoma in situ (DCIS). Negative axillary nodal status determined by sentinel node biopsy or axillary dissection. Eligible for and willing to have adjuvant endocrine therapy. Not planned for adjuvant chemotherapy or biologic anti-cancer therapy. Participants are randomised to ARM A: RT + endocrine therapy or ARM B: no RT (endocrine therapy only). Primary indpoint is local recurrence free interval. Patient Reported Outcomes: data is available from 433 English-speaking patients from PROM measuring Fear of Cancer Recurrence (FCR Inventory), Convenience of Care (study specific), Fatigue (Brief Fatigue Inventory), Endocrine Therapy (19 endocrine-symptom items from the FACT-ES), Anxiety and Depression (Hospital Anxiety and Depression Scale), QALY (EQ-5D-5L). A health economic analysis will also be performed. Demographic data has been collected Age and Race/ethnicity.

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