HER2 negative operable breast cancer
Conditions
Interventions
Administrate 4 cycles of FEC after 4 cycles of nab-Paclitaxel. Operation is to be performed after chemotherapy. nab-Paclitaxel(260mg/m2) intravenously on day 1 of each 3-weeks. FEC(5-Fluorourac
Sponsors
Kinki Breast Cancer Study Group-Translational Research (KBCSG-TR)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Primary breast cancer patients who are diagnosed as invasive breast cancer by needle biopsy or tissue biopsy. 2) T1c-3, N0-1, M0 and tumor size is less than 7 cm. 3) Invasive lesion of the primary lesion is confirmed as HER2 negative (IHC 0-1+ or, if IHC 2+ -> FISH negative). 4) Enrollmental age between 20 years old and 65 years old. 5) ECOG performance status (PS):0-1 6) Results from a laboratory test meet the following : - Neutrophil count is >=1,500/mm3 - Platelet >= 100,000/mm3 - Hemoglobin >= 10.0 g/dL - AST <= 3 times of upper limit of normal (ULN) - ALT <= 3 times of upper limit of normal (ULN) - Total bilirubin < 1.5 mg/dL - Creatinine < 1.5 mg/dL 7) No clinical abnormality by electrocardiography. 8) No interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan. 9) Evaluate images of the primary lesion before and after treatment by CT, MRI. The evaluation must be conducted by the same modality (At an allergy for contrast media, the omission is permissible). 10) Evaluate images of the primary lesion before and after treatment by ultrasonic diagnosis. The evaluation must be conducted by the same modality 11) No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy. 12) Considered eligible to neoadjuvant chemotherapy based on decision of the attending physician after considering other treatments such as surgery, chemotherapy, hormone therapy, radiation therapy. 13) Urinary or serum HCG negative when menopause is not confirmed (excluding patients underwent ovariectomy or hysterectomy). 14) Signed written informed consent.
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity to any agents necessary in the planned treatment. 2) Poorly controlled complication. 3) Active infectious disease or Fever with suspected infection. 4) Symptoms of varicella. 5) Serious edema. 6) Serious peripheral neuropathy. 7) Positive for HBs antigen, except for not under the appropriate antiviral medication 8) Complication which requires prior pre-treatment with corticosteroid. 9) Previous history or receiving treatment of dementia or serious psychiatric disorder. 10) Heterochrony or synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS). 11) Active multiple cancer (Non-invasive tumor or disease free periods after treatment are more than two years, considered to be non-activity). 12) Treatment with anticancer agent within five years. 13) Ineligible based on decision of an investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Safety(adverse events, incidence of cardiac disorders) (2) Overall response rate (3) Breast conserving rate (4) QpCR rate (5) CpCR and pN0 rate (6) SpCR rate | — |
Countries
Japan
Contacts
Public ContactTakahiro Nakayama
Kinki Breast Cancer Study Group-Translational Research (KBCSG-TR) Adminstrative office
Outcome results
None listed