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

NCT03756298 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2026-04-23

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • National Cancer Center, Korea

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03756298 on ClinicalTrials.gov