HER2-negative primary breast cancer
Conditions
Interventions
Neoadjuvant chemotherapy with 4 cycles of dose-dense (every 2 week) Nab-PTX (260mg/m2) followed by 4 cycles of dose-dense (every 2 week) EC therapy (epirubicin 90 mg/m2 and CPA 600 mg/m2). Pegfilgrast
including goshajinkigan (7.5 g/day), mecobalamin (1,500 ug/day) and lafutidine (20 mg/day).
Sponsors
Teikyo University School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Female breast cancer histologically diagnosed HER2-negative primary invasive breast cancer 2) Stage 1-3 3) No previous treatment for breast cancer 4) 20 years old or older 5) Performance Status (PS) 0-1 6) Results from a laboratory test meet the following: Leukocyte count is >=3000/mm3 or Neutrophil count is >=2000/mm3 Platelet >=100 000/mm3 Hemoglobin >=9.0g/dL AST and ALT <=x 1.5 of upper limit of normal (ULN) Total bilirubin <=x 1.5 of ULN Serum creatinine <=x 1.5 of ULN 7) No poorly controlled complication 8) Signed written informed consent
Exclusion criteria
Exclusion criteria: 1) Women who are pregnant or lactating 2) Multiple primary cancer 3) HER2-positive breast cancer 4) Poorly controlled complication (interstitial pneumonia, severe diabetes, heart failure, renal insufficiency, hepatic insufficiency) 5) Active infection 6) Serious peripheral neuropathy (>=CTCAE grade2) 7) Ineligible based on decision of an investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response rate, disease-free survival, adverse events, the evaluation of peripheral neuropathy by Patient Neurotoxicity Questionnaire (PNQ), the evaluation of QOL by FACT-Taxane | — |
Countries
Japan
Contacts
Public ContactHiromitsu Jinno
Teikyo University School of Medicine Department of Surgery
Outcome results
None listed