breast cancer
Conditions
Interventions
Neoaduvant chemotherapy with Docetaxel+Carboplatin+Trastuzumab
Sponsors
Kanagawa Breast Oncology Group (KBOG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) invasive breast cancer by needle biopsy 2) operable primary breast cancer 3) HER2 positive (IHC 3+ or FISH +) 4) ER, PgR known 5) P.S. = 0~1 6) measurable lesions 7) preserving the functions of bone marrow, heart, liver, and kidney 8) written informed consent
Exclusion criteria
Exclusion criteria: 1) drug allergy 2) severe complications (malignant hypertension, congestive heart failure, coronary heart disease, myocardial infarction (onset within 6 months), arrhythmia (treated), infectious disease, bleeding tendency, etc) 3) feber, infection 4) peripheral neuropathy 5) pleural effusion, pericardial effusion 6) active double cancer 7) inflammatory breast cancer 8) bilateral breast cancer, male breast cancer 9) pregnancy 10) severe edema 11) interstitial pneumonia, fibrous lung disease 12) steroid-using patients 13) psychosomatic disease 14) unsuitable patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac adverse events, Breast-conserving rate, Clinical response rate, Relapse-free survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactYasuyuki Kojima, M.D.
St. Marianna University School of Medicine Department of Surgery, Division of Breast and Endocrine Surgery
Outcome results
None listed