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. 2023 Dec 14;9:99. doi: 10.1038/s41523-023-00591-6

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