Primary Chemotherapy With Anthracycline Followed by Nab-p... | NCT01432223

Studies
Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

NCT01432223

Sponsor

Osaka Medical College

Status

Completed

Last Update Posted

Apr 22, 2015Estimated

Enrollment

46Actual

Phase

Phase 2

Conditions

Breast Cancer
HER-2 Positive Breast Cancer
Effects of Chemotherapy

Interventions

Nab-paclitaxel

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UMIN000006288	Registry Identifier	University hospital Medical Information Network

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Nov 2013Actual

Completion Date

May 2014Actual

First Submitted Date

Sep 8, 2011

First Submission Date that Met QC Criteria

Sep 9, 2011

First Posted Date

Sep 12, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2015

Last Update Posted Date

Apr 22, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nab-paclitaxel	Experimental	Nab-paclitaxel q3w 260mg/m2	Drug: Nab-paclitaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nab-paclitaxel	Drug	Nab-paclitaxel 260mg/m2 q3w	Nab-paclitaxel	Abraxane

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Disease free survival		5 years from the last patient enrolled
Overall response rate		After the protocol therapy
Pathological response rate

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Mitsuhiko Iwamoto, MD, PhD	Osaka Medical College	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Osaka Medical College		Takatsuki	Osaka	5698686	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25579459	Result	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
C520255	130-nm albumin-bound paclitaxel
D000068196	Albumin-Bound Paclitaxel

ID	Term
D017239	Paclitaxel
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840