Overview

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