UMIN-CTR Clinical Trial

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	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)
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)
Scientific Title:Acronym	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)
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

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	2
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
Last 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
1st 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
Institute	KBCSG-TR(Kinki Breast Cancer Study Group-TR)
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010175