Tailored Neoadjuvant Chemotherapy for Stage II/III Breast Cancer With Tumor Size More Than 2 cm

• Status: Completed
• Trial end date: 2017-04-19
• Target enrollment: 0
• Participant gender: Female

Summary

This is a multi-center randomized phase III trial. The purpose is to evaluate and compare the pathological complete response (pCR) rates after neoadjuvant chemotherapy with tailored chemotherapeutic regimens or standard chemotherapy for stage II/III breast cancer with tumor size more than 2 cm.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Docetaxel; Epirubicin

Criteria

Inclusion Criteria:

• Histologically confirmed invasive, but non-inflammatory, breast carcinoma, with stage II or III disease (AJCC 7th ed)

• And, tumor size more than 2 cm in greatest diameter measured by estimated by CT scan or MRI

• Documented Her2/neu negative , including score 0, 1+, or 2+ by immunohistochemistry

• No prior radiotherapy, hormonal therapy or chemotherapy for invasive breast cancer

• Performance status of ECOG 0, 1,

• Female with age older than 20 years

• Laboratory parameter

• Absolute neutrophil count (ANC) ≧1500/mm3

• Total bilirubin ≦2.0 times the upper limit of normal (ULM)

• AST or ALT ≦2.5 times the upper limit of normal (ULM)

• Platelets ≧100,000/mm3

• Serum creatinine ≦1.5 x ULM

• Fasting triglyceride ≧ 70 mg/dL

• Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

• Evidence of metastatic breast cancer or inflammatory breast cancer

• Bilateral breast cancer, metaplastic carcinoma, or mucinous carcinoma

• Known allergy to any of the study drugs or to agents containing Cremophor.

• Serious intercurrent infections or medical illnesses that are uncontrolled or the control of which may be jeopardized by this therapy

• Psychiatric disorders or other conditions regarding the subject incapable of complying with the requirements of the protocol

• Evidence of baseline sensory or motor neuropathy

• Pregnant or breast feeding women

• Previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ with a disease-free interval of at least 5 years