UMIN-CTR Clinical Trial

Public title

Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer

Acronym

Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer

Scientific Title

Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer

Scientific Title:Acronym

Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer

Region

Japan

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluate the efficacy and safety of EC followed by weekly Nab-paclitaxel as neoadjuvant chemotherapy for primary breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

pathological complete response rate

Key secondary outcomes

adverse event
clinical response rate
pathological response rate
rate of breast-conserving surgery
feasibility
overexpression rate of SPARC

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

4 cycles of EC followed by 4 cycles of weekly nab-paclitaxel

EC
Epi-ADM 90 mg/m2 and CPA 600 mg/m2 administered intravenously on day 1 of each 3-week cycle

weekly nab-paclitaxel
nab-paclitaxel 150 mg/m2 administered weekly on days 1, 8, and, 15 of each 4-week cycle

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

Histologically confirmed primary breast cancer

Clinical stage T1c-3 N0/M0 or T1-3 N1/M0

At least one measurable lesion

over 20 years old

No prior surgery, radiation, chemotherapy and endocrine therapy

Adequate baseline organ function (within 14 days before registration)
Hb--over 8.0 g/dL
WBC--over 3000 /mm3 and under 12,000 /mm3
Neu--over 2,000 / mm3
Plt--over 75,000 / mm3
T-Bil--under 3 times ULM
AST/ALT--under 3 times ULN
Cre--under ULN

ECOG performance status--0-2

written informed consent

Key exclusion criteria

past medical history of drug allergy

HER2 positive breast cancer
(IHC 3+, IHC 2+ and FISH +)

Active double cancer

Severe complications

Symptomatic brain metastasis

Severe mental disorder

History of blood transfusions within 2 weeks

Sever bone marrow suppression, renal dysfunction, liver dysfunction

Body cavity fluid

watery diarrhea on registration

Active infection or potentiality infection

allergic reaction of the nab-paclitaxel, paclitaxel or albumin


During pregnancy or lactation

Judged by the investigator to be unfit to be enrolled into the study

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Yasuhiro Suzuki

Organization

Tokai University School of Medicine

Division name

Division of Breast and Endocrine Surgery, Department of Surgery

Zip code

Address

143 Shimokasuya, Isehara-shi, Kanagawa, Japan 259-1193

TEL

+81-463-93-1121

Email

luke-szk@is.icc.u-tokai.ac.jp

Name of contact person

1st name
Middle name
Last name	Yasuhiro Suzuki

Organization

Tokai University School of Medicine

Division name

Division of Breast and Endocrine Surgery, Department of Surgery

Zip code

Address

143 Shimokasuya, Isehara city, Kanagawa, Japan, 259-1193

TEL

+81-463-93-1121

Homepage URL

Email

luke-szk@is.icc.u-tokai.ac.jp

Institute

Tokai University School of Medicine

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

07

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2011

Year

07

Month

22

Day

Date of IRB

Anticipated trial start date

2011

Year

08

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

07

Month

22

Day

Last modified on

2019

Year

01

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007125