UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004345
Receipt number R000005201
Scientific Title Phase II clinical trial of the combination of high-dose toremifene and exemestane for advanced/recurrent breast cancer unresponsive to nonsteroidal aromatase inhibitors
Date of disclosure of the study information 2010/10/07
Last modified on 2015/07/28 09:48:28

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Basic information

Public title

Phase II clinical trial of the combination of high-dose toremifene and exemestane for advanced/recurrent breast cancer unresponsive to nonsteroidal aromatase inhibitors

Acronym

Phase II clinical trial of the combination of high-dose toremifene and exemestane for advanced/recurrent breast cancer unresponsive to nonsteroidal aromatase inhibitors

Scientific Title

Phase II clinical trial of the combination of high-dose toremifene and exemestane for advanced/recurrent breast cancer unresponsive to nonsteroidal aromatase inhibitors

Scientific Title:Acronym

Phase II clinical trial of the combination of high-dose toremifene and exemestane for advanced/recurrent breast cancer unresponsive to nonsteroidal aromatase inhibitors

Region

Japan


Condition

Condition

Advanced/recurrent breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We confirmed the effectiveness and safety of combination therapy with 120 mg of toremifene citrate and exemestane in patients with postmenopausal breast cancer who showed recurrence during or after nonsteroidal aromatase inhibitors as postoperative adjunctive therapy or therapy for recurrence.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Clinical benefit

Key secondary outcomes



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

Daily oral administration of 120 mg (60 mg x 2 tablets) of toremifene and 25 mg/day of exemestane

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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1. Patients who provided written informed consent by themselves in principle to participate in this trial
2. Postmenopausal females with breast cancer in whom the primary lesion was confirmed to be breast cancer by histological or cytological examination
3. Patients who showed recurrence during or after the administration of anastrozole or letrozole as postoperative adjunctive therapy or therapy for progression/recurrence
4. Patients not using other endocrine therapy or chemotherapy drugs after the completion of aromatase inhibitor administration
5. Patients with a lesion allowing measurement or only bone metastasis
6. ER(+) and/or PgR(+) patients
7. Patients expected to survive for 3 months or more
8. Patients with a performance status (ECOG) of 0, 1, or 2 9. Patients with adequately maintained heart/liver/kidney/bone marrow functions and fulfilling the following conditions
(1) Hb level:  9g/d
(2) AST(GOT), ALT(GPT):  2.5 times the normal limit at the institution

Key exclusion criteria

1. Patients with active double cancer
2. Patients with life-threatening symptoms, extensive organ metastasis (1/3 of the organ), or brain metastasis
3. Patients with a past history of severe drug hypersensitivity
4. Pregnant or breastfeeding females
5. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Sakaguchi

Organization

Kyoto Prefectural University of Medicine

Division name

Endocrine & Breast Surgery

Zip code


Address

465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kyoto Prefectural University of Medicine

Division name

Endocrine & Breast Surgery

Zip code


Address

465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

TEL


Homepage URL


Email



Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

Organization

Division

Category of Funding Organization

Self funding

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

2010 Year 10 Month 07 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

2010 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2010 Year 04 Month 01 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

2010 Year 10 Month 06 Day

Last modified on

2015 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005201


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name