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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004752
Receipt No. R000005613
Scientific Title Evaluation of the Usefulness of Pre-operative Exemestane (EXE) Therapy for Treatment of Hormone-Sensitive Breast Cancer in Postmenopausal Patients, and EXE + TC Combination Therapy for Nonresponders to EXE Therapy. (JBCRG-11TC)
Date of disclosure of the study information 2010/12/20
Last modified on 2019/03/28

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Basic information
Public title Evaluation of the Usefulness of Pre-operative Exemestane (EXE) Therapy for Treatment of Hormone-Sensitive Breast Cancer in Postmenopausal Patients, and EXE + TC Combination Therapy for Nonresponders to EXE Therapy. (JBCRG-11TC)
Acronym JBCRG-11TC
Scientific Title Evaluation of the Usefulness of Pre-operative Exemestane (EXE) Therapy for Treatment of Hormone-Sensitive Breast Cancer in Postmenopausal Patients, and EXE + TC Combination Therapy for Nonresponders to EXE Therapy. (JBCRG-11TC)
Scientific Title:Acronym JBCRG-11TC
Region
Japan

Condition
Condition ER positive, HER2 negative, Stage II or IIIA [T2-3,N0-2,M0], Primary Postmenopausal Invasive Breast Cancer Patients
Classification by specialty
Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Exemestane will be administered to postmenopausal women with primary, resectable, hormone receptor-positive, Stage II or IIIA [T2-3, N0-2, -M0] breast cancer with a Ki67 index of 30% or under.
Exemestane will be continued in those whose tumor shows 5% or under low proliferation with a Ki67 index and those who respond to it,whereas combination therapy of exemestane + TC therapy will be given to those who do not respond to exemestane. The study is aimed to examine the clinical response rate of the primary cancer and evaluable axillary lymph node metastasis to each therapy. At the same time, the histological effects, safety, clinical efficacy and relevance to the Ki67 index as well as the breast-conserving surgery rate, relapse-free survival and overall survival will be assessed. In addition, the antitumor effects as well as biological properties of the cancer tissue and the underlying mechanisms of resistance to Exemestane will be investigated using molecular biological and biochemical techniques.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Clinical response at Week 24 and Week 36
Key secondary outcomes (1) Histological response rate
(2) Survival and relapse-free survival: To examine the tumor regression effect between Week 8 and 12, and at Week 24 and 36 and the correlation with Ki67 index values before and after the treatment
(3) Clinical benefit: Breast-conserving surgery rate, axillary lymph node metastasis positive rate (reduction rate from the baseline status), local relapse rate
(4) To explore clinicopathologic and molecular biological markers related to the tumor regression effect and long-term prognostic prediction
(5) Development of adverse events: To verify the safety

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Exemestane will be administered to postmenopausal women with primary, resectable, hormone receptor-positive, Stage II or IIIA [T2-3, N0-2, -M0] breast cancer with a Ki67 index of 30%. Exemestane will be continued in those whose tumor shows under 5% low proliferation with a Ki67 index and those who respond to it.
Interventions/Control_2 Exemestane will be administered to postmenopausal women with primary, resectable, hormone receptor-positive, Stage II or IIIA [T2-3, N0-2, -M0] breast cancer with a Ki67 index of 30%. Exemestane will be continued with combination therapy of exemestane + TC will be given to those who do not respond to exemestane.
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
65 years-old >
Gender Female
Key inclusion criteria (1) Invasive breast cancer confirmed by biopsy (excluding lobular carcinoma and mucinous adenocarcinoma)
(2) T2-T3, N0-2, M0 (In case of multiple ipsilateral breast cancer, all lesions should be histopathologically diagnosed)
(3) ER positive on immunohistological staining (positive stained cells over1%)
(4) HER2 negative (IHC: 1+ or 0, or FISH: HER2/CEP17 <1.8 [or mean copy number of HER2 gene <4 for each nucleus])
(5) Ki67 index less than 30%
(6) No previous treatments
(7) ECOG Performance Status (P.S.): 0 - 1
(8) Any of the followings in which the surgical procedure is expected to result in improvement by the preoperative treatment
[1]Although partial mastectomy is indicated, the risk of positive margins or any cosmetic matters are involved.
[2]Total mastectomy is indicated.
(9) Either the presence or absence of axillary lymph node metastasis is acceptable.
(10) Cases with any of the following postmenopausal criteria is met
[1]Amenorrhea for at least one year
[2]Menopause due to bilateral ovariectomy or radiation
[3]FSH over 30 mIU/mL and E2 <10 pg/mL
(11) Principal organs (bone marrow, heart, liver, kidneys, etc.) are functionally preserved.
[1]White blood cell count >=3,000/mm3 or
Neutrophil count >=1,500/mm3
[2]Platelet count >=100,000/mm3
[3]Hemoglobin >=9.0 g/dL
[4]AST, ALT <=2.5 x Upper limit of facility reference
[5]Total bilirubin <=1.5 x Upper limit of facility reference
[6]Serum creatinine <=1.5 x Upper limit of facility reference
(12) Physician judges an indication for preoperative hormone therapy, taking other treatments such as surgery, preoperative chemotherapy, and preoperative hormone therapy into consideration.
(13) Written informed consent
Key exclusion criteria (1) Prior treatment for the breast cancer by chemotherapy or hormone therapy
(2) Medication that may affect the sex hormone status (hormone replacement therapy, raloxifene, etc.) (eligible if the last dose was at least two months before)
(3) Past history of breast cancer or presence of active multiple cancers (eligible if DCIS is located on the other side)
(4) Bilateral breast cancer (if tumors on both sides meet the eligibility criteria, the case is not excluded.)
(5) Cases for whom non-hormonal therapies such as surgical therapy, chemotherapy, or antibody therapy are recommended as the first treatment of choice
(6) Past history of hypersensitivity to any drug or contrast agent used in this study
(7) Cases in which another study drug is given for a disease other than breast cancer
(8) Cases in which study participation is considered difficult due to the coexistence of psychosis or psychiatric symptoms
(9) Cases considered ineligible by the attending physician for other reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuaki Sato
Organization Niigata Cancer Center Hospital
Division name Department of Surgery
Zip code
Address 2-15-3 Chuo-Ku, Kawagishi-cho
TEL 025-266-5111
Email nobus@niigata-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsumasa Kuroi
Organization Japan Breast Cancer Research Group (JBCRG)
Division name Head Office
Zip code
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL 03-6264-8873
Homepage URL
Email office@jbcrg.jp

Sponsor
Institute Japan Breast Cancer Research Group (JBCRG)
Institute
Department

Funding Source
Organization Japan Breast Cancer Research Group (JBCRG)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 新潟県立がんセンター(新潟県)
都立駒込病院(東京都)
熊本大学医学部附属病院(熊本県)
八尾市立病院(大阪府)
三菱京都病院(京都府)
大阪医療センター(大阪府)
京都大学医学部附属病院(京都府)
北海道がんセンター(北海道)
福井赤十字病院(福井県)
虎の門病院(東京都)
呉医療センター・中国がんセンター(広島県)
西脇市立西脇病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 20 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 10 Month 29 Day
Date of IRB
2010 Year 11 Month 22 Day
Anticipated trial start date
2010 Year 11 Month 23 Day
Last follow-up date
2026 Year 03 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
2010 Year 12 Month 18 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005613

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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