Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

Osaka Medical College

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Effects of Chemotherapy

HER-2 Positive Breast Cancer

Treatments

Drug: Nab-paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT01432223

OMC-BC01

UMIN000006288 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated.

Anthracycline-based regimen (d1, q3w):

EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2)

Nab-paclitaxel 260mg/m2 (d1, q3w)

Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.

Enrollment

46 patients

Sex

Female

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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