NCT03756298

Efficacy and Safety of Atezolizumab Plus Capecitabine Adjuvant Therapy for Triple Receptor-Negative Breast Cancer

Randomized, Phase II Trial to Evaluate the Efficacy and Safety of Atezolizumab Plus Capecitabine Adjuvant Therapy Compared to Capecitabine Monotherapy for TNBC With Residual Invasive Cancer After Neoadjuvant Chemotherapy.

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study will enroll patients who received neoadjuvant therapy for TNBC prior to surgery and did not get pCR. Given the relatively poor prognosis for these patients, this population is considered novel therapeutic as adjuvant treatment. Currently, capecitabine monotherapy could be beneficial to this group of patients according to CREATE-X trial results. The investigators are addressing the effect of anti-PD-L1, atezolizumab combined with capecitabine in patients with TNBC who did not get pCR after neoadjuvant chemotherapy compared to capecitabine monotherapy.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab is 1,200 mg iv. administered every 3 weeks for 8 cycles with capecitabine (2,000mg/m2/day, day 1-14, every 3 weeks for 8 cycles)
DRUG	Capecitabine	capecitabine monotherapy (2,500mg/m2/day, day 1-14, every 3 weeks for 8 cycles)

Timeline

• Start date: 2019-01-15
• Primary completion: 2024-01-31
• Completion: 2027-01-31
• First posted: 2018-11-28
• Last updated: 2023-11-09

Locations

1 site across 1 country: South Korea