UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000008662
Receipt number	R000010175
Scientific Title	A Randomized Phase II Study of Maintenance Hormone Therapy with or without Capecitabine after Induction Chemotherapy with Bevacizumab plus Paclitaxel in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer (KBCSG-TR1214)
Date of disclosure of the study information	2012/08/09
Last modified on	2019/03/22 16:15:59

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Basic information

Public title

A Randomized Phase II Study of Maintenance Hormone Therapy with or without Capecitabine after Induction Chemotherapy with Bevacizumab plus Paclitaxel in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer (KBCSG-TR1214)

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Breast cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To investigate efficacy and safety of maintenance hormone therapy with or without capecitabine for hormone receptor positive and HER2 negative metastatic or recurrent breast cancer after induction chemotherapy with bevacizumab + paclitaxel. In addition, to investigate efficacy and safety of reintroduction of maintenance therapy with bevacizumab + paclitaxel after diseasse progression.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Assessment

Primary outcomes

Progression free survival of maintenance therapy

Key secondary outcomes

Time to failure of strategy, response rate of reintroduction therapy, progression free survival of reintroduction therapy, time to treatment failure of reintroduction therapy, overall survival from first registration , safety

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Hormone therapy: treatment of physician's choice (TPC)

Interventions/Control_2

Hormone therapy + capecitabine:
hormone therapy, treatment of physician's choice (TPC); capecitabine; 1,657 mg/m2/day orally in 2 divided doses for 3 weeks followed by 1week rest

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)Signed written informed consent
(2)Female >=20 years old
(3)Advanced breast cancer with distant metastases or inoperable recurrent breast cancer
(3)Estrogen reseptor positive assessed by immunohistochemistory (IHC
(5)HER2 negative*
*FISH negative or IHC <=2+; IHC =2+ has to be tested by FISH for negative status
(6)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
(7)Life expectancy of at least 12 months
(8)With measurable lesoin defined by RECIST version 1.1 With stimative diseases, e.g. small lesions (long-axis diameter <10 mm or short-axis diameter of pathological lymph nodes >=10 and <15mm) only, bone lesions only, mediastinum disease only, diffuse skin lesions only are allowed.
(9)Previously treated with no more than one chemotherapy regimen for metastatic or inoperable recurrent breast cancer
(10)Efficacy from hormone therapy is expected
(11)No previous treatment with paclitaxel (including nab-paclitaxel) or oral fluoropyrimidines. Eligible if paclitaxel or oral fluoropyrimidines were administered only in neo-adjuvant or adjuvant setting, or 12 months prior to registration.
(12)No effect from previous treatments and examinations
(13)Adequate organ function defined by the following laboratory values (within 2 weeks prior to first dose):
Absolute neutrophil count >=1,500/mm3
Platelets >=100x104/mm3
Hemoglobin >=9.0g/dL
Serum bilirubin <=1.5 mg/dL
AST and ALT <=100 IU/L(<=200 in patients with known liver involvement)
Serum creatinine <=1.5 mg/dL
Proteinuria <=1+

Key exclusion criteria

(1)Prior therapy with bevacizumab
(2)Hypersensitivity to paclitaxel or drugs using the vehicle Cremophor,
chinese hamster ovary cell derived products or other recombinant humanized antibodies
(3)Hypersensitivity to capecitabine or fluoropyrimidines
(4)Clinically or radiographically confirmed brain metastases
(5)Treated brain metastasis within 3 months prior to registration
(6)Women who is pregnant, lactating or declined contraception
(7)Obvious infection or inflammation (with fever >= degrees centigrade
(8)Active hepatitis
(9)Patients with a nonhealing wound or fracture.
(10)Massive pleural effusion, ascites or cardiac effusion
(11)Uncontrolled hypertension (SBP>150 mmHg, DBP>100 mmHg).
(12)Patients receiving anticoagulant therapy within 10 days prior to registration (aspirin <=325 mg/day is allowed.), or patients need anticoagulant therapy during study
(13)Under coutinuous corticosteroid administration.
(14)Symptomatic congestive heart failure,unstable angina, uncontrolled arrhythmia, myocardial infarction within 12 months prior to study entry.
(15)Idiopathic pulmonary fibrosis, interstitial lung disease
(16)Current or previous history (within 12 months) of symptomatic cerebrovascular disease
(17)Current or previous history (within 12 months) of deep vein thrombosis or pulmonary embolism.
(18)Current or previous history (within 12 months) of GI perforation
(19)Active peptic ulcer
(20)Planned surgery within study term
(21)Synchronous or metachronous tumors with <5 years disease-free period
(22)Symptomtic peripheral neuropathy with functional disorders.
(23)Patients ineligible to the study based on decision of attending physician or site principal investigators.

Target sample size

120

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Norikazu Masuda

Organization

National Hospital Organization, Osaka National Hospital

Division name

Department of Surgery, Breast Oncology

Zip code

Address

1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka

TEL

06-6942-1331

Email

nmasuda@alpha.ocn.ne.jp

Public contact

Name of contact person

1st name

Middle name

Last name Norikazu Masuda

Organization

National Hospital Organization, Osaka National Hospital

Division name

Department of Surgery, Breast Oncology

Zip code

Address

1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka

TEL

06-6942-1331

Homepage URL

Email

nmasuda@alpha.ocn.ne.jp

Sponsor or person

Institute

KBCSG-TR(Kinki Breast Cancer Study Group-TR)

Institute

Department

Personal name

Funding Source

Organization

The Supporting Center for Clinical Research and Education (SCCRE)

Organization

Division

Category of Funding Organization

Non profit foundation

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2012 Year 08 Month 09 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

Completed

Date of protocol fixation

2012 Year 07 Month 24 Day

Date of IRB

2012 Year 07 Month 31 Day

Anticipated trial start date

2012 Year 08 Month 01 Day

Last follow-up date

2018 Year 05 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2012 Year 08 Month 09 Day

Last modified on

2019 Year 03 Month 22 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010175

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name