HER2 positive breast cancer
Conditions
Interventions
1)FEC-TCH therapy group: 4 cycles of FEC therapy * (5-fluorouracil (5-FU) + epirubicin (EPI) + cyclophosphamide (CPA)) followed by 4 cycles of TCH therapy ** (docetaxel (DTX) + cyclophosphamide (CPA)
5-FU (500 mg/m2, q3w), epirubicin (100 mg/m2, q3w), cyclophosphamide (500 mg/m2, q3w) **TCH regimen: 1 cycle is 3 weeks
docetaxel (75 mg/m2, q3w), cyclophosphamide (600 mg/m2, q3w)
2)TCH-FEC therapy group: 4 cycles of TCH therapy** followed by 4 cycles of FEC therapy
3)TCH therapy group: 6 cycles of TCH therapy
Sponsors
Japan Breast Cancer Research Group (JBCRG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Female primary breast cancer patients who are diagnosed as invasive breast cancer by needle biopsy or tissue biopsy. 2)Resectable primary breast cancer (T1c-3 N0-1 M0) and tumor size is 7 cm or smaller. Multiple ipsilateral breast cancer is eligible when at least 1 lesion meets the eligible criteria. However, each lesion has to be histologically evaluated. 3)Invasive lesion of the primary lesion is confirmed as HER2 positive (IHC 3+ or FISH+). 4)Status of ER and PgR are confirmed by immunohistochemical staining. 5)Age between 20 years old and 70 years old 6)ECOG performance status (PS): 0-1 7)Results from a laboratory test meet the following: a)Leukocyte count is >=4000/mm3 and <=12 000/mm3 or neutrophil count is >=2000/mm3 b)Hemoglobin >=9.0g/dL c)Platelet >=100 000/mm3 d)AST and ALT <=x 2.5 of upper limit of normal (ULN) e)Bilirubin (total bilirubin or direct bilirubin) <=ULN f)Serum creatinine <=x 1.5 of ULN 8)Baseline left ventricular ejection fraction (LVEF) is >=55% measured by echocardiography or MUGA scan. 9)No QTc prolongation by electrocardiography (QTc is <=470 msec). 10)No interstitial pneumonia or pulmonary fibrosis diagnosed by chest CT scan. 11)Evaluate images of the primary lesion before and after treatment by CT, MRI or ultrasound. The evaluation must be based on the same modality. 12)No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy. 13)Considered eligible to neoadjuvant chemotherapy based on decision of the attending physician after considering other treatments such as surgery, chemotherapy, hormone therapy. 14)Urinary or serum HCG negative when menopause is not confirmed (excluding patients underwent ovariectomy or hysterectomy). 15)Signed written informed consent
Exclusion criteria
Exclusion criteria: 1)Hypersensitivity to any agents necessary in the planned treatment. 2)Poorly controlled complication (malignant hypertension, myocardial infarction within 6 months, congestive heart failure, coronary insufficiency, arrhythmia which requires treatment, infection and bleeding). 3)Fever with suspected infection. 4)Symptoms of varicella. 5)Pleural effusion or cardiac effusion which requires treatment. 6)Serious edema. 7)Serious peripheral neuropathy 8)Complication which requires prior treatment with corticosteroid. 9)Regular use of H2 blocker. 10)Has history of or receiving treatment for serious psychiatric disorder. 11)Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS). 12)Multiple primary cancer or has history of multiple primary cancer in the past 5 years. However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer. 13)History of invasive breast cancer. 14)History of multiple primary cancers in the past 5 years excluding nonmelanoma skin cancer, cervical cancer, thyroid cancer, early gastric cancer and early colorectal cancer appropriately treated. 15)Prior treatment with anticancer agents. 16)Cardiac disorder diagnosed by echocardiography. 17)Women who are pregnant, lactating or with childbearing potential. 18)Ineligible based on decision of an investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete rseponse rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, incidence of cardiac disorders, clinical response rate, overall survival, breast conservation rate and rate without axillary lymph node dissection | — |
Countries
Japan
Contacts
Public ContactKatsumasa Kuroi
Japan Breast Cancer Research Group (JBCRG) Adminstrative office
Outcome results
None listed