UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026050
Receipt number R000029938
Scientific Title Phase II study to assess efficacy, safety & immunological biomarker of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer
Date of disclosure of the study information 2017/02/08
Last modified on 2019/02/07 06:04:51

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Phase II study to assess efficacy, safety & immunological biomarker of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer

Acronym

KBCRN-B-001

Scientific Title

Phase II study to assess efficacy, safety & immunological biomarker of anti PD-L1 antibody + anti CTLA-4 antibody in combination with hormone therapy in patients with hormone receptor positive HER2-negative recurrent or metastatic breast cancer

Scientific Title:Acronym

KBCRN-B-001

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate efficacy and safety of anti-PD-L1 antibody drug + anti-CTLA-4 antibody drug in combination with hormone therapy in patients with inoperable or recurrent hormone-receptor-positive and HER2-negative breast cancer with distant metastasis. Also, the immunological biomarkers affecting therapeutic effect will be investigated.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

Response rate based on RECIST1.1

Key secondary outcomes

Duration of response
Disease control rate
Progression-free survival
Response rate based on irRECIST
ORR(RECIST 1.1, irRECIST), DOR,DCR in continuous administration


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Durvalumab 1500mg, every 4 weeks(up to 13 cycles)
Tremelimumab 75mg, every 4 weeks (up to 4 cycles)
Fulvestrant 500 mg, first day, 2weeks later and 4weeks laetr. And then 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1)Patients aged >= 20 years at informed consent.
2)Patients who have provided written informed consent themselves.
3)Patients who have metastatic and/or advanced lesion
4)Documentation of ER-positive and/or PR-positive tumor (>=1% positive stained cells).
5)Patients with cancer confirmed to be HER2-negative.
6)Patients with confirmed menopause
7)Patients who have plans of 2nd hormone therapy.
8)Patients with a measurable lesion based on RECIST 1.1
9)Patients with ECOG PS of 0 to 1.
10)Patients without any severe disorder in the major organs.

Key exclusion criteria

1)Active or prior documented autoimmune disease within the past 2 years.
2)Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab
3)Patients with central nervous system metastasis
4)Patients with life-threatening disease.
5)Patients with a history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 or anti-CTLA-4 antibody drug.
6)Patients who have received live vaccination within 30 days before start of the investigational products.
7)Patients with a past medical history of pneumonia requiring steroid treatment or with a past medical history of interstitial pneumonia.
8)Patients considered ineligible for participation in this study by their attending physicians.

Target sample size

33


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masakazu Toi

Organization

Kyoto University Graduate School of Medicine

Division name

Breast Surgery

Zip code


Address

54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, Japan

TEL

075-751-3660

Email

toi@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuo Sakamoto

Organization

General Incorporated Association Kyoto Breast Cancer Research Network

Division name

KBCRN Study Office

Zip code


Address

9-5 Higashimaruta-cho, Sakyo-ku, Kyoto 606-8395 Japan

TEL

075-761-5751

Homepage URL


Email

k-study@ibec-jp.com


Sponsor or person

Institute

Breast Cancer Research Network

Institute

Department

Personal name



Funding Source

Organization

AstraZeneca

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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 08 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

Terminated

Date of protocol fixation

2016 Year 12 Month 05 Day

Date of IRB


Anticipated trial start date

2017 Year 12 Month 27 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 08 Day

Last modified on

2019 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029938


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name