A phase III randomized study of neoadjuvant chemotherapy including trastuzumab + cyclophosphamide + docetaxel in patients with operable HER2 positive breast cancer (JBCRG 10)

UMIN ID: UMIN000002365

Registered date:31/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: HER2 positive breast cancer
• Date of first enrollment: 2009/08/01
• Target sample size: 180
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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) + trastuzumab (H)) *FEC regimen: 1 cycle is 3 weeks; 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

Outcome(s)

• Primary Outcome: pathological complete rseponse rate
• Secondary Outcome: Safety, incidence of cardiac disorders, clinical response rate, overall survival, breast conservation rate and rate without axillary lymph node dissection

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude 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.

Related Information

• Primary Sponsor: Japan Breast Cancer Research Group (JBCRG)
• Source(s) of Monetary Support: Japan Breast Cancer Research Group (JBCRG)