UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001217
Receipt number 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 17:01:38

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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 or person

Institute

The Japan-Multinational Trial Organization

Institute

Department

Personal name



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

Value
https://center6.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