3.7. Outcome assessment

The primary outcome will be the changes in peripheral blood T lymphocyte subsets (CD8⁺, CD4⁺, CD3⁺, and CD4⁺/CD8⁺ T-cell ratio). We will assess the primary outcome at baseline, week 1 and week 2 of treatment, and at follow up at the 3rd and 4th weeks after the end of treatment.

The secondary outcomes will include the KPS score and the EORTC QLQ-C30 score to assess the patient’s quality of life. And the outcomes will be assessed at baseline, week 2 and week 4. Furthermore, 5-year survival rate and recurrence rate in the two groups will be evaluated. The patients were followed up every 3 months in the 1st to 2nd years for breast ultrasound examination, every 6 months in the 3rd to 5th years.