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dose-dense AC or EC therapy followed by dose-dense Paclitaxel as neoadjuvant chemotherapy for triple negative operable breast cancer

dose-dense AC or EC therapy followed by dose-dense Paclitaxel as neoadjuvant chemotherapy for triple negative operable breast cancer - PerSeUS-BC05

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040187
Enrollment
35
Registered
2020-06-01
Start date
2020-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breasr cancer

Interventions

1.dose-dense Adriamycin(60mg/m2),cyclophospamide(600mg/m2)or Epirubicin90mg/m2,cyclophosphamide(600mg/m2) 4courses(2qw) 2.dose-dense paclitaxel(175mg/m2) 4courses(2qw)

Sponsors

Gifu University Graduate School of Medicine Department of Surgical Oncology
Lead Sponsor
Gihoku kosei hospital Gifu municipal hospital Gifu prefectual general medical center Ibi kosei hospital Daiyukai general hospital Takayama red cross hospital Kizawa memorial hospital Asahi Univ.hospital
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1)Patients with breast cancer 2)triple negative typr 3)StageI-IIIB 4)Curable by neoadjuvant chemotherapy ans surgery 5)cases with measurable lesion 6)age20-69 at registration 7)PS(ECOG)0-1 8)No therapy before registration 9)LVEF>50% by UCG 10)WBC>3000/mm3 Neutrophil>1500/mm3 Platelet<10,000/mm3 Hb>9.0g/dL AST(GOT)<ULNx3 ALT(GPT)<ULNx3 T-Bil<2mg/dL Cr<2mg/dL 11)informed consent obtained from IC 12)To evaluate lymph node, not only CT/PET/US, but sentinel node biopsy/cytligy may be preferable.

Exclusion criteria

Exclusion criteria: 1)inflammamatory and/or bilateral breast cancer 2)Duplicated/sunchromus/metachromus cancer(DFS less than 5y) 3)Severe complication(cardiovascular, lung, liver disease, homorragic ulcer etc.) 4)febrile, suspicious for infection 5)Intedstitial pneumonia oe pulmonary fibrosis by chest-X/CT 6)Active systhemic infection()HBV,HCV,HIC etc.) 7)Severe allergy to drug 8)Pregnancy,Lactation 9)Uncontrollable mental disease 10)Not suitable for thes study judged by physician/Surgeon

Design outcomes

Primary

MeasureTime frame
pCR rate—

Secondary

MeasureTime frame
Response rate Pathological evaluation Breast conserving rate Safety(change of LVEF,Febrile neutropenia,CIPN,Pneumocystis pneumonia) Relative dose intensity Aduvant therapy DFS OS Evaluation of TILs/PD-L1 in biopsy samples Analysis of tumor-related factors in urine and blood(Pre,after 4*dose-dense AC or EC, after*4 dose-dense paclitaxel)—

Countries

Japan

Contacts

Public ContactYoshimi Asano

Gifu University Graduate School of Medicine Department of Surgical Oncology

yasano@gifu-u.ac.jp058-230-6000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026