Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Osaka Medical College
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Trastuzumab

Criteria

Inclusion Criteria:

• Histologically confirmed invasive breast cancer

• T1c-3 N0-2a

• Confirmed of hormonal receptor status

• HER2 positive confirmed by IHC 3+ or FISH+

• LVEF > 50% by echocardiogram or MUGA

• Adequate EKG

• No prior treatment for breast cancer

• PS 0-1

• Required baseline laboratory data WBC > 4,000/mm3 and Neut > 2,000/mm3 PLT > 100,000/mm3 Hb > 9.0g/dl AST and ALT < ULNx2.5 T-Bil < 1.5mg/dl Serum creatinin < 1.5mg/dl

• Written informed consent

Exclusion Criteria:

• With history of hypersensitivity reaction for important drug in this study

• With history of invasive breast cancer

• Bilateral invasive breast cancer

• Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus

• Positive for HBs antigen and with history of HVB

• With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension

• With severe edema

• With severe peripheral neuropathy

• With severe psychiatric disorder

• Pregnant or nursing women

• Cases who physician judged improper to entry this trial