Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01432223

Enrollment

Registered

2011-09-12

Start date

2011-09-30

Completion date

2014-05-31

Last updated

2015-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Effects of Chemotherapy, HER-2 Positive Breast Cancer

Keywords

Trastuzumab, Neoadjuvant chemotherapy, Primary chemotherapy

Brief 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.

Detailed 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.

Interventions

DRUGNab-paclitaxel

Nab-paclitaxel 260mg/m2 q3w

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
To evaluate the pathological complete response rate	1 year from last patient enrolled

Secondary

Measure	Time frame
Disease free survival	5 years from the last patient enrolled
Overall response rate	After the protocol therapy
Pathological response rate	After the protocol therapy
Breast-conserving surgery rate	After the protocol therapy
Safety	Within the protocol thepapy

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026