UMIN-CTR Clinical Trial

Public title

Phase II study of gemcitabine and trastuzumab in patients with metastatic breast cancer

Acronym

SBP-01

Scientific Title

Phase II study of gemcitabine and trastuzumab in patients with metastatic breast cancer

Scientific Title:Acronym

SBP-01

Region

Japan

Condition

Metastatic breast cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate efficacy and safety of gemcitabine plus trastuzumab in chemotherapy and trastuzumab-pretreated patients with metastatic breast cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Objective response rate

Key secondary outcomes

Progression free survival, Overall survival, Adverse events rate

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -but assessor(s) are 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

Combination treatment of gemcitabine and trastuzumab
gemcitabine 1250mg/m2 day1,8 21days cycle
trastuzumab 2mg/kg (Initial dose 4mg/kg) q1w
continuing treatment until disease progression

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) Signed written informed consent
2) Age over 20 years.
3) ECOG performance Status 0-2
4) Histologically confirmed adenocarcinoma of the breast
5) HER2-positive in the tissue of primary breast cancer or metastatic sites.
6) Patients must have measurable disease that is evaluable according to RECIST 1.1
7) LVEF over 50% at baseline
8) Adequate organ function
9) Prior combination treatment with trastuzumab and chemotherapy
10) Expectation of more than 3 months survival

Key exclusion criteria

1) Active double cancer
2) Brain metastases that requiring treatment at registration
3) Unstable angina pectoris, congestive heart failure, myocardial infarction, or ventricular arrhythmia requiring medication within 6 months to registration
4) Uncontrolled hypertension or diabetes mellitus.
5) Active infection disease
6) Other severe, uncontrolled systemic disease
7) Over grade 3 hypersensitivity reaction to trastuzumab
8) Hormonal therapy, chemotherapy, or biological treatment <7days prior to registration
9) Radiation therapy <14days prior to registration
10) Prior gemcitabine therapy
11) Current pregnancy and lactation
12) Assessment by the investigator to be unsuitable to comply with the requirements of the protocol

Target sample size

42

Name of lead principal investigator

1st name
Middle name
Last name	Fumikata Hara

Organization

National Hospital Organization Shikoku Cancer Center

Division name

Department of medical oncology

Zip code

Address

160 Minami Umemoto Ko, Matsuyama, Ehime, Japan 7910280

TEL

089-999-1111

Email

hfumikat@shikoku-cc.go.jp

Name of contact person

1st name
Middle name
Last name	Naruto Taira

Organization

Setouchi Breast Project Comprehensive Organization

Division name

Clinical Research Group

Zip code

Address

2-5-1 Shikata Kita-ku Okayama Okayama Japan, 7008558

TEL

086-235-7265

Homepage URL

Email

info@setouchi-bp.com

Institute

Setouchi Breast Project Comprehensive Organization

Institute

Department

Personal name

Organization

Setouchi Breast Project Comprehensive Organization

Organization

Division

Category of Funding Organization

Other

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

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Background: There are few evidence on efficacy of Tmab-containing regimens after disease progression. Gemcitabine (GEM) is non-cross resistant to anthracycline and taxane. Preclinical studies have shown that the combination of Tmab and GEM has synergistic effect against HER2-positive breast cancer cell lines. SBP-01 study assessed the efficacy and safety of the combination of Tamb and GEM in patients with HER2-positive MBC previously treated with anti-HER2 therapy. Methods: SBP-01 study included patients treated with one or more anti-HER2 directed regimens for MBC. Patients were administered with GEM 1250 mg/m2 on days 1 and 8 of each 21-day cycle and Tmab 4mg/kg loading dose and then 2mg/kg weekly. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression free survival (PFS), overall survival, and safety. Results: Between June 2011 and June 2014, 35 patients were enrolled. Patients had ER positive tumor (37.1%), a median of 2 metastatic organ sites, visceral metastasis (80.0%), prior (neo) adjuvant Tmab (22.9%) and a median of 2 prior chemotherapy regimens for MBC. Previous HER2-directed drugs included Tmab (94.3%), lapatinib (37.1%), T-DM1 (8.6%) and pertuzumab (2.9%). ORR was 22.9% (95% CI, 8.6%-36.8%). Median PFS was 146 days. Patients with stable disease response received a median of 7 cycles (6-28 cycles) of treatment. Grade3/4 leukopenia (20.0%) and neutropenia (48.6%) were observed. All non-hematological toxicities were less than grade3. Conclusions: The Combination Tmab and GEM is effective and well-tolerated regimen for patients previously treated with HER2-directed therapy, and appears to make disease stable for long time period.

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

Main results already published

Date of protocol fixation

2011

Year

06

Month

16

Day

Date of IRB

Anticipated trial start date

2011

Year

07

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

06

Month

29

Day

Last modified on

2016

Year

01

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006944