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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Jan 31, 2024 to Dec 31, 2026
    • Study completion date: Jan 31, 2027 to Dec 31, 2027
    v6
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study site revised
    v3
  5. Interventions: Atezolizumab (Drug) to Atezolizumab (Drug), Capecitabine (Drug)
    • Study title shortened, about 14 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03756298
Lead Sponsor National Cancer Center, Korea
Conditions
(from sponsor)		 Triple Negative Breast Cancer
Related terms Triple Negative Breast Neoplasms
Enrollment 284 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov