UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026143
Receipt number R000030036
Scientific Title Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer
Date of disclosure of the study information 2017/02/20
Last modified on 2020/02/18 13:44:45

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Basic information

Public title

Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer

Acronym

Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer

Scientific Title

Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer

Scientific Title:Acronym

Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer

Region

Japan


Condition

Condition

HER2-negative primary breast cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of dose-dense Nab-PTX followed by EC as neoadjuvant chemotherapy for HER2-negative primary breast cancer. To evaluate the effect of cryotherapy and compression therapy using stockings, and prophylactic medication including goshajinkigan, mecobalamin and lafutidine for prevention of nab-PTX- induced peripheral neuropathy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Pathological complete response rate

Key secondary outcomes

Clinical response rate, disease-free survival, adverse events, the evaluation of peripheral neuropathy by Patient Neurotoxicity Questionnaire (PNQ), the evaluation of QOL by FACT-Taxane


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment

Interventions/Control_1

Neoadjuvant chemotherapy with 4 cycles of dose-dense (every 2 week) Nab-PTX (260mg/m2) followed by 4 cycles of dose-dense (every 2 week) EC therapy (epirubicin 90 mg/m2 and CPA 600 mg/m2). Pegfilgrastim (3.6mg) will be administered on day2 or 3 of every cycle.
Patients will receive cryotherapy using ice and wear elastic stockings during nab-PTX administration, and will receive prophylactic medication over the course of treatment; including goshajinkigan (7.5 g/day), mecobalamin (1,500 ug/day) and lafutidine (20 mg/day).

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1) Female breast cancer histologically diagnosed HER2-negative primary invasive breast cancer
2) Stage 1-3
3) No previous treatment for breast cancer
4) 20 years old or older
5) Performance Status (PS) 0-1
6) Results from a laboratory test meet the following:
Leukocyte count is >=3000/mm3 or
Neutrophil count is >=2000/mm3
Platelet >=100 000/mm3
Hemoglobin >=9.0g/dL
AST and ALT <=x 1.5 of upper limit of normal (ULN)
Total bilirubin <=x 1.5 of ULN
Serum creatinine <=x 1.5 of ULN
7) No poorly controlled complication
8) Signed written informed consent

Key exclusion criteria

1) Women who are pregnant or lactating
2) Multiple primary cancer
3) HER2-positive breast cancer
4) Poorly controlled complication (interstitial pneumonia, severe diabetes, heart failure, renal insufficiency, hepatic insufficiency)
5) Active infection
6) Serious peripheral neuropathy (>=CTCAE grade2)
7) Ineligible based on decision of an investigator

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Hiromitsu
Middle name
Last name Jinno

Organization

Teikyo University School of Medicine

Division name

Department of Surgery

Zip code

173-8606

Address

2-11-1 Kaga, Itabashi-ku, Tokyo, Japan

TEL

+81-3-3964-1211

Email

jinno@med.teikyo-u.ac.jp


Public contact

Name of contact person

1st name Hiromitsu
Middle name
Last name Jinno

Organization

Teikyo University School of Medicine

Division name

Department of Surgery

Zip code

173-8606

Address

2-11-1 Kaga, Itabashi-ku, Tokyo, Japan

TEL

+81-3-3964-1211

Homepage URL


Email

jinno@med.teikyo-u.ac.jp


Sponsor or person

Institute

Teikyo University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Teikyo University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Teikyo university institutional review board

Address

2-11-1 Kaga, Itabashi-ku, Tokyo, Japan

Tel

03-3964-7256

Email

turb-office@teikyo-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2017 Year 01 Month 12 Day

Date of IRB


Anticipated trial start date

2017 Year 02 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 02 Month 15 Day

Last modified on

2020 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030036


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name