Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

NCT ID: NCT01432223

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-05-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nab-paclitaxel

Nab-paclitaxel q3w 260mg/m2

Group Type: EXPERIMENTAL

Nab-paclitaxel

Intervention Type: DRUG

Nab-paclitaxel 260mg/m2 q3w

Interventions

Nab-paclitaxel

Nab-paclitaxel 260mg/m2 q3w

Intervention Type: DRUG

Other Intervention Names

Abraxane

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Osaka Medical College

OTHER

Sponsor Role: lead

Responsible Party

Satoru Tanaka

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mitsuhiko Iwamoto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Osaka Medical College

Locations

Osaka Medical College

Takatsuki, Osaka, Japan

Countries

Japan

References

Tanaka S, Iwamoto M, Kimura K, Matsunami N, Morishima H, Yoshidome K, Nomura T, Morimoto T, Yamamoto D, Tsubota Y, Kobayashi T, Uchiyama K. Phase II Study of Neoadjuvant Anthracycline-Based Regimens Combined With Nanoparticle Albumin-Bound Paclitaxel and Trastuzumab for Human Epidermal Growth Factor Receptor 2-Positive Operable Breast Cancer. Clin Breast Cancer. 2015 Jun;15(3):191-6. doi: 10.1016/j.clbc.2014.12.003. Epub 2014 Dec 24.

Reference Type: RESULT

PMID: 25579459 (View on PubMed)

Other Identifiers

UMIN000006288

Identifier Type: REGISTRY

Identifier Source: secondary_id

OMC-BC01

Identifier Type: -

Identifier Source: org_study_id