UMIN-CTR Clinical Trial

Public title

Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with metastatic breast cancer (KSCOG-BC04)

Acronym

Phase II study of weekly nanoparticle albumin-bound paclitaxel (KSCOG-BC04)

Scientific Title

Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with metastatic breast cancer (KSCOG-BC04)

Scientific Title:Acronym

Phase II study of weekly nanoparticle albumin-bound paclitaxel (KSCOG-BC04)

Region

Japan

Condition

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of weekly nab-paclitaxel therapy for metastatic breast cancer

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Response Rate

Key secondary outcomes

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

Nab-paclitaxel 100mg/m2 on days 1, 8, 15

<HER2 positive>
Nab-paclitaxel 100mg/m2 on days 1, 8, 15
Trastuzumab* : 2mg/kg , Day 1, 8, 15, 22
*4 mg/kg for the initial dosing (day 1)
Cycles are repeated every 4 weeks.

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

1) Written informed consent to participate
2) Suitable judgement by physician
3) Histological and/or cytological confirmed breast cancer
4) Metastatic breast cancer
5) The below criteria are met about prior therapy
a. chemotherapy: more than 14 days passed after prior chemotherapy.
b. hormonal therapy: more than 7 days passed after hormonal therapy
c. radiation: more than 14 days passed after radiation.
6) Age 20 or over
7) Performance status (ECOG) 0-2
8) Has measurable lesion with CT within 28 days according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
9) The below criteria met within 14 days prior to therapy
1.WBC between 3,000/mm3 and 12,000/mm3
2.Granulocyte count 1,500/mm3 or over
3.Platelet count 100,000/mm3 or over
4.Hb 9.0 g/dl or over
5.Total bilirubin 2.0 mg/dL or under
6.AST(GOT) 100 IU/L or under
7.ALT(GPT) 100 IU/L or under
8.Serum creatinine 1.5 mg/dl or under
9.(only HER2 positive) Left ventricle ejection fraction 55 % or over by cardiac sonography or MUGA scan
10) Expected survival longer than 3 months

Key exclusion criteria

1) Anamnesis of hypersensitivity to drugs(especially paclitaxel or albumin)
2) Ttreatment history of taxanes (paclitaxel or docetaxel) for metastatic breast cancer
3)Peripheral neuropathy Grade2 or over
4) Pregnancy, or suspected pregnancy
5)Severe Infection (38 degrees or over)
6)Severe complication (interstitial pneumonia or pulmonary fibrosis, renal failure, hepatic failure, uncontrolled diabetes, uncontrolled hypertension and so on)
7) ECG abnormalities
8)Heart failure with clinically problem (cardiac failure, cardiac infarction, angina, cardiac valvulopathy)
9) Active secondary malignancy within 5 years of disease free interval(but, registerable for cured cutaneous basal cell carcinomas and cervical cancer, cured gastric cancer, esophageal cancer and pm-colorectal cancer by endoscopic mucosal resection)
10)Pleural effusion, ascites, and pericardial effusion that need treat
11) Symptomatic brain metastasis
12)Consecutive systemic administration of steroids
13)Physician judged improper to entry this trial

Target sample size

55

Name of lead principal investigator

1st name
Middle name
Last name	Toh Uhi

Organization

Kurume University School
of Medicine

Division name

Department of Surgery

Zip code

Address

67 Asahi-machi,Kurume city,Fukuoka

TEL

0942-31-7566

Email

utoh@med.kurume-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Toh Uhi

Organization

Kurume University School

Division name

Department of Surgery

Zip code

Address

67 Asahi-machi

TEL

0942-31-7566

Homepage URL

Email

utoh@med.kurume-u.ac.jp

Institute

Department of Surgery, Kurume University School of Medicine

Institute

Department

Personal name

Organization

Department of Surgery, Kurume University School of Medicine

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

2012

Year

09

Month

05

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

06

Month

20

Day

Date of IRB

Anticipated trial start date

2011

Year

09

Month

28

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

09

Month

05

Day

Last modified on

2019

Year

01

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010404