UMIN-CTR Clinical Trial

Public title

Phase II study of EC followed by Nab-paclitaxel as neoadjuvant chemotherapy for HER2 negative with lymph node metastases

Acronym

Phase II study of EC followed by Nab-paclitaxel as neoadjuvant chemotherapy for HER2 negative with lymph node metastases

Scientific Title

Phase II study of EC followed by Nab-paclitaxel as neoadjuvant chemotherapy for HER2 negative with lymph node metastases

Scientific Title:Acronym

Phase II study of EC followed by Nab-paclitaxel as neoadjuvant chemotherapy for HER2 negative with lymph node metastases

Region

Japan

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study was to assess the efficacy and safety of EC Followed by Nab-paclitaxel as neoadjuvant chemotherapy for HER2 negative with lymph node metastases

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

pathological complete response rate

Key secondary outcomes

clinical response rate, pathological response rate, rete of breast conserving surgery, adverse event

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 tri-weekly Nab-paclitaxel
[EC]
epirubicin 90 mg/m2 and CPA 600 mg/m2 administered intravenously on day 1 of each 3-week cycle
[Nab-paclitaxel]
Nab-paclitaxel 260 mg/m2 administered intravenously on day 1 of each 3-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

70

years-old

>=

Gender

Female

Key inclusion criteria

1)Histologically confirmed primary breast cancer
2)Clinical stage T1-3,>=N1,M0
3)Expected to radical cure by operation and neoadjuvant chemotherapy
4)At least one measurable lesion
5)Age >=20 and <= 70
6)No prior surgery, radiation, chemotherapy and endocrine therapy
7)adequate function of important organs (within 14 days before registaration)
1. Hemoglobin: >=9.0g/dL
2. WBC: >=4,000/mm3 or Neutrophil: >=2,000/mm3
3. Platelet: >=100,000/mm3
4. T-Bil <= 1.5mg/dL
5. AST <= ULN x 2.5
6. ALT <= ULN x 2.5
7. Creatinin <= 1.5mg/dL
8. Adequate baseline cardiac function on Electrocardiography
8)ECOG performance status 0-1
9)written informed consent
10)Judged eligible based on physicians' decision

Key exclusion criteria

1)History of hypersensitivity reaction
2)Active another cancer
3)Other severe complications, such as uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months, heart failure.
4)Severe mental disorder
5)Sever bone marrow suppression, renal dysfunction, liver dysfunction
6)Body cavity fluid
7)Active infection or potentiality infection
8)Pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant
9)Judged ineligible based on physicians' decision

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Maki Nakai

Organization

Saitama Medical Center,
Saitama Medical University

Division name

Division of breast and endocrine Surgery

Zip code

Address

Kamoda 1981, Kawagoe-shi, Saitama 350-8550, Japan

TEL

049-228-3464

Email

Name of contact person

1st name
Middle name
Last name

Organization

Saitama Medical Center,Saitama Medical University

Division name

Division of breast and endocrine Surgery

Zip code

Address

TEL

049-228-3756

Homepage URL

Email

Institute

Saitama Medical Center,Saitama Medical University

Institute

Department

Personal name

Organization

Saitama Medical Center,Saitama Medical University

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

2013

Year

05

Month

17

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

Enrolling by invitation

Date of protocol fixation

2012

Year

12

Month

20

Day

Date of IRB

Anticipated trial start date

2013

Year

05

Month

18

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

05

Month

10

Day

Last modified on

2013

Year

05

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012456