UMIN-CTR Clinical Trial

Public title

Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer

Acronym

Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer

Scientific Title

Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer

Scientific Title:Acronym

Phase I/II study of Gemcitabine plus weekly Paclitaxel with Metastatic Breast Cancer

Region

Japan

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate maximum tolerated dose to determine recommended dose of gemcitabine and weekly paclitaxel in inoperable and/or metastatic breast cancer patients. In the next phase, we evaluate the safety and efficacy with recommended dose for these patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

To determine maximum tolerated dose and recommended dose

Key secondary outcomes

adverse events
time to progression

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

The optimal dosage of gemcitabine plus paclitaxel is decided by the dose limiting toxicity

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

75

years-old

>

Gender

Female

Key inclusion criteria

histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer

HER2 negative

over 20 years old, under 75 years old

ECOG performance status--0 or 1

All Pts are
1--after receiving anthracycline containing regimen for neoadjuvant and adjuvant setting, but no prior chemotherapy for metastatic disease including taxanes must have been completed more than 12 months before registering in this study
2--after receiving one regimen for locally advanced breast cancer including taxanes must have been completed more than 12 months before registering in this study

Patients who have passed the following periods from previous treatment
1--immunotherapy/endocrinetherapy
14 days from the final administration,
in case of LH-RH analogue, 28 days are
needed
2--chemotherapy
28 days
3--radiation therapy
28 days
4--operation
7 days

Key exclusion criteria

Prior administration of gemcitabine

Pulmonary fibrosis or pneumonitis

Abnormal cardiac function, myocardial infarction within 6 months

Body cavity fluid which needs to treatment

Active infection

Severe complicated situation

Severe drug allergic reaction

Serious psychiatric illness

After bone marrow transplantation

After stem cell transplantation

Symptomatic systemic brain metastasis

Double chemotherapy

Pregnancy, breast feeding, suspected pregnancy

Target sample size

47

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 city, 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
Division of Breast and Endocrine Surgery
Department of Surgery

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

In 1000mg/m2 of gemcitabine dose, DLT was observed in one case of 6 patienrs. This DLT was grade 4 neutropenia. And in 1250mg/m2 of gemcitabine dose, no DLT was observed. Finaly, recomended dose will be 1250mg/m2 of gemcitabine.

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

Completed

Date of protocol fixation

2011

Year

03

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

04

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

21

Day

Last modified on

2018

Year

02

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005291