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JBCRG-22 (Neo-Entrance)
A multicenter randomized phase II clinical trial with neo -adjuvant chemotherapy containing eribulin mesylate for triple negative primary breast cancer patients (Neo-Entrance study)
- Status
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No Longer Recruiting
- Objectives
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To evaluate the efficacy and safety of neo -adjuvant chemotherapy based on eribulin mesylate for primary triple negative breast cancer
- Subjects
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- Endpoints
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Primary outcomes： Pathological complete response evaluated by the Central Decision Institution [CpCRypN0 (ypT0-TisypN0)] Secondary outcomes： - SpCR, SpCR and pN0 rate - CpCR rate - QpCR, QpCR and pN0 rate - Clinical response rate (response rate of eribulin-based, anthracycline treatments and overall response rete) - Breast-conserving surgery rate - The rate of patients with axillary lymph nodes negative at the time of surgery which have been diagnosed as node positive before NAC. - Disease-free Survival (DFS), Invasive Disease-free survival (IDFS), overall survival (OS) (DFS, IDFS, and OS will be examined in an observational study after the completion of the investigator initiated clinical trial) - Influence of an eribulin combination regimen on the effects of the second half of the regimen (anthracycline) - Influence (e.g., neutrophil counts) of blood toxicity on Days 8 and 15 in Cycle 1 of the eribulin combination regimen on the therapeutic effects of eribulin and the effects of the second half of the regimen (anthracycline) - Influence (e.g., neutrophil counts) of blood toxicity on Days 8 and 15 in Cycle 1 of the paclitaxel combination regimen on the therapeutic effects of paclitaxel and the effects of the second half of the regimen (anthracycline) - Safety in each treatment groups (adverse events, completion rates, and dose intensity)
- Trial Period
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-30 Sep 2019
- Lead Principal Investigator
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Kyoto University Graduate School of Medicine Masakazu Toi National Hospital Organization Osaka National Hospital Norikazu Masuda
- Target Sample Size
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200
- Regimen
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eribulin
- Source of Funding
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Eisai Co., Ltd.
- Conference Presentation
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Genomic profile and response prediction of eribulin mesylate based neoadjuvant chemotherapy in triple negative breast cancer patients
Immune microenvironment, homologous recombination deficiency and therapeutic response to neoadjuvant chemotherapy in triple negative breast cancer: JBCRG22 TR
Longitudinal alteration of cytokine profile in the peripheral blood and clinical response for neoadjuvant chemotherapy in triple-negative breast cancer patients (Translational Research of the JBCRG-22 Trial)
A randomized, phase 2 study of neoadjuvant chemotherapy containing eribulin mesylate for triple-negative primary breast cancer patients stratified by homologous recombination deficiency status (JBCRG-22)
- Articles and Publications
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Immune microenvironment, homologous recombination deficiency and therapeutic response to neoadjuvant chemotherapy in triple negative breast cancer : Japan Breast Cancer Research Group (JBCRG)22 TR
Eribulin-based neoadjuvant chemotherapy for triple-negative breast cancer patients stratified by homologous recombination deficiency status: a multicenter randomized phase II clinical trial (JBCRG-22)
- UMIN-ID
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UMIN000023162
- jRCT
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- Memo
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- COI Disclosure
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