Table 5.
Ongoing Clinical Trials.
EUROPA N = 926 | REaCT trial N =100 | |
---|---|---|
Inclusion criteria | Women Aged ≥70 Years with Luminal A-like tumors (defined as ER ≥ 10%, PR > 20%, HER2 negative, with Ki67 < 20%) | Women > 70 years with grade 1 T size ≤ 5 cm, grade 2 T-size ≤ 3 cm, or grade 3 T-size ≤ 1 cm. N0, ER + HER2- |
Randomization | Lump + Endocrine therapy (ET) vs Lump + PBI alone | Lump or mastectomy + ET x 5 years vs Lump or mastectomy + No ET |
Endpoint |
Primary Endpoints: • HRQol using the EORTC QLQ-C30 • Time to ipsilateral breast tumor recurrence Secondary Endpoints: • HRQoL EORTC B23, QLQ ELD14 • Locoregional relapse, contralateral • Distant relapse, • Breast cancer specific survival • Overall survival • Adverse events • Cosmesis |
Primary Endpoints: • Accrual of 100 participants across 8 centers within 2 years after study initiation • A participation rate of at least 60% among participants approached. • At least 90% of enrolled participants receive treatment as per their allocated intervention for at least 4 weeks Secondary Endpoints: • Significant adverse events • ET related Toxicity • FACT B- Endocrine Symptom Subscale (FACT-B plus ES). • CARG patient tool |