At a glance
ClinicalIndex Comparison RecordPhase 2Recruiting· 106 target
Drug / intervention
Induction therapydrug
Likely dose
Not stated in record
Key inclusion· 12
- ✓Metastatic, recurrent, or unresectable advanced TNBC
- ✓PD-L1 positivity confirmed by SP142 IC ≥1
- ✓At least 6 months from completion of curative treatment to first recurrence
- ✓ECOG performance status 0-1
Key exclusion· 24
- ✕Active brain metastases or carcinomatous meningitis
- ✕History of invasive malignancy within 3 years (exceptions: basal cell, squamous cell carcinoma of skin, or carcinoma in situ)
- ✕Concurrent or metachronous bilateral invasive breast cancer (unless both TNBC and PD-L1 positive)
- ✕Radiotherapy within 14 days prior to enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT06793553Phase 2RecruitingMonitorUpdated 17mo ago · Completion was 3mo agoSlow Enrollment
Monitor
Randomized Phase II Trial Evaluating the Efficacy of Paclitaxel+Bevacizumab INDUCtion Followed by at atEzolizumab+Nab-paclitaxel for PD-L1-positive Metastatic Triple Negative Breast Cancer (JBCRG-M10, CMA-0196) (INDUCE Trial)
In Brief
A Phase 2 clinical trial evaluating Induction therapy for Metastatic Breast Cancer. Currently recruiting, targeting 106 participants across 1 site.
Signals
Enrolling slower than its timeline implies
Detailed Summary
The objective of this research is to evaluate the efficacy of the treatment strategy to administer atezolizumab + nab-paclitaxel (PTX) following 2 cycles of induction therapy with PTX + bevacizumab (induction treatment strategy) in programmed cell death ligand-1 (PD-L1)-positive metastatic triple-negative breast cancer (mTNBC) in comparison with the standard atezolizumab + nab-PTX therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesJapan
CollaboratorsChugai Pharmaceutical
Timeline
Phase 2Recruiting
2025202620272028
Enrollment StartSep 2024
First PostedJan 2025
Primary CompletionMar 2026
TodayJul 2026
Study CompletionSep 2028
First PostedJan 27, 2025
Enrollment StartSep 13, 2024
Primary CompletionMar 31, 2026
Study CompletionSep 30, 2028
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 1.4 years ago
Interventions
Induction therapydrug
2 cycles of PTX+ bevacizumab induction therapy followed by atezolizumab+nab-PTX