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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001217
Receipt No. R000001486
Scientific Title Investigation of the clinical effects of combination therapy using LH-RH analogue + Anastrozole on patients with hormone receptor positive, premenopausal advanced/recurrent breast cancer resistant to combination therapy using LH-RH analogue + Tamoxifen
Date of disclosure of the study information 2008/06/29
Last modified on 2013/04/26

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Basic information
Public title Investigation of the clinical effects of combination therapy using LH-RH analogue + Anastrozole on patients with hormone receptor positive, premenopausal advanced/recurrent breast cancer resistant to combination therapy using LH-RH analogue + Tamoxifen
Acronym JMTO BC08-01
Scientific Title Investigation of the clinical effects of combination therapy using LH-RH analogue + Anastrozole on patients with hormone receptor positive, premenopausal advanced/recurrent breast cancer resistant to combination therapy using LH-RH analogue + Tamoxifen
Scientific Title:Acronym JMTO BC08-01
Region
Japan

Condition
Condition Premenopausal breast cancer
Classification by specialty
Surgery in general Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness and safety of combination therapy using LH-RH analogue + Anastrozole on patients with advanced/recurrent breast cancer in whom combination therapy using LH-RH analogue + Tamoxifen, the standard hormone therapy for hormone receptor positive, premenopausal breast cancer, has been a failure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Clinical response rate
Key secondary outcomes 1.Progression free survival
2.Overall survival
3.Clinical benefit rate
4.Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Goserelin acetate 3.6mg depot/ q 4w + Anastrozole 1mg/d
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
55 years-old >=
Gender Female
Key inclusion criteria Patients fulfilling the following criteria
1.Premenopausal women at least 20 years old and no more than 55 years old [at time of registration]
2.Patients in whom metastatic or recurrent breast cancer has been confirmed
3.Patients with a measurable lesion [RECIST handling] or assessable bone lesion
4.Patients who have shown resistance to combination therapy with LH-RHa + TAM in prior treatment
Patients falling under any of 1 to 4 below
1 Recurrence during postoperative therapy using LH-RHa + TAM
2 Recurrence within 1 year following the completion of postoperative therapy lasting 2 years or more using LH-RHa + TAM
3 Recurrence during postoperative TAM monotherapy in continuation of postoperative therapy lasting 2 years or more using LH-RHa + TAM or recurrence within 1 year following the completion of TAM monotherapy
4 Patients whose symptoms have worsened under combination therapy using LH-RHa + TAM for advanced/recurrent breast cancer 5.ER or PgR positive patients [positive ratio of 10% or more using IHC method]
6.PS 0-1 patients [ECOG Performance Status classification]
7.Among patients being administered a bisphosphonate, patients who have a measurable non-bone lesion in which anticancer effects can be followed up 8.Patients with no serious complications who fulfill the following criteria in clinical laboratory tests
WBC at least 4,000/microL and no more than 10,000/microL
PLT at least 100,000 /microL
Hb at least 10g/dL
T.Bil. no more than 1mg/dL
AST no more than 60 IU/L
ALT no more than 60 IU/L
9.Informed consent must have been obtained from the patient in writing in regard to participation in the trial
Key exclusion criteria Patients falling under any of the following
1.Patients with a history of drug allergy against the test drug and co-administered drug
2.Patients administered another anticancer drug since the prior treatment [LH-RHa + TAM therapy or LH-RHa + TAM followed by TAM therapy]
3.Patients receiving ongoing systemic administration [orally or intravenously] of an adrenal cortex hormone
4.Patients with advanced cancer in another organ less than 5 years after the completion of treatment
5.Patients with a history of thrombotic disease such as deep vein thrombosis or cerebral infarction
6.Patients with a history of severe heart disease such as myocardial infarction, valvular heart disease or heart failure 7.Patients receiving administration of HRT for treatment of menopausal symptoms within 4 weeks of registration
8.Women who are pregnant, lactating or may be [intend to be] pregnant
9.Patients planning treatment with an anticancer drug other than LH-RHa + Anastrozole, a bisphosphonate or radiation therapy on a target lesion following the start of this trial
10.Other cases who the doctor responsible for the trial judges unsuitable
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Reiki Nishimura
Organization Kumamoto City Hospital
Division name Breast & Endocrine Surgery
Zip code
Address 1-1-60 Kotoh, Kumamoto City, Kumamoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The Japan-Multinational Trial Organization
Division name Operating Office
Zip code
Address
TEL 075-241-4894
Homepage URL
Email

Sponsor
Institute The Japan-Multinational Trial Organization
Institute
Department

Funding Source
Organization The Japan-Multinational Trial Organization
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
2008 Year 06 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.spandidos-publications.com/or/29/5
Number of participants that the trial has enrolled
Results ONCOLOGY REPORT Vol: 29 No: 5 1707-1713 (May 2013).

Title:
Efficacy of goserelin plus anastrozole in premenopausal women with advanced or recurrent breast cancer refractory to an LH-RH analogue with tamoxifen: Results of the JMTO BC08-01 phase II trial.

Results:
Between September 2008 and November 2010, 37 patients were enrolled. Thirty-five patients (94.6%) had ER-positive tumors, and 36 (97.3%) had human epidermal growth factor receptor (HER) 2-negative tumors. Thirty-six (97.3%) had measurable lesions and 1 (2.7%) had only bone metastasis. The ORR was 18.9% [95% confidence interval (CI), 8.0-35.2%], the CBR was 62.2% (95% CI, 44.8-77.5%) and the median PFS was 7.3 months. Eight patients had adverse drug reactions but none resulted in discontinuation of treatment. GOS plus ANA is a safe effective treatment for premenopausal women with hormone receptor-positive, recurrent or advanced breast cancer. The treatment may become viable treatment in the future, particularly when TAM is ineffective or contraindicated. Further studies and discussion are warranted.
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
2008 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2008 Year 09 Month 01 Day
Last follow-up date
2011 Year 11 Month 01 Day
Date of closure to data entry
2012 Year 01 Month 01 Day
Date trial data considered complete
2012 Year 04 Month 01 Day
Date analysis concluded
2012 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 06 Month 29 Day
Last modified on
2013 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001486

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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