UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-23)
Title of the study (Brief title)	Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-23)
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 clarify the following doubts regarding preoperative Exemestane therapy:(1)the level of difference in sensitivity towards preoperative endocrine therapy has on chemotherapy administered, (2)how useful PEPI score is, and (3)the level of positive margin when breast-conserving surgery is conducted after administering preoperative endocrine therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Prior to administering preoperative Exemestane, assess the possibility of administering postoperative chemotherapy and whether this possibility of administering chemotherapy changes after treatment {Examine whether chemotherapy will be administered and whether it really is administered (determined by primary physician) based on the eligibility criteria}
Key secondary outcomes	(1) Response rate, tumor size (palpation and diagnostic imaging), type of surgery, rate of positive resection margins in breast-conserving surgery, PEPI score {lymph node metastasis, pathological tumor size, ER, Ki67}, pathological therapeutic efficacy, PgR, HER2, other biomarkers, disease-free survival rate, recurrence-free survival rate, overall survival rate, safety

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Inclusion criteria (1)Female patients whose primary lesion is histologically diagnosed as invasive ductal breast cancer (incision biopsy, needle biopsy or mammotome biopsy is conducted); (2)Stage IIA-IIIA;(3)Postmenopausal - Patients that fulfill one of the following criteria: (a) amenorrheic for 1 year or more, (b) menopause caused by bilateral oophorectomy or radiation, (c) FSH is 30mIU/ml or more and E2 is less than 10pg/ml, (d) 60 years or older;(4)Patients without any prior treatment;(5)ER positive and HER2 negative - (a) ER positive: 10% or more of the breast cancer cells are positive, (b) HER2 negative: 0 or 1+ on the Hercep test or, if a 2+, must be less than 1.8 times on FISH (or DISH), (c) immunohistochemical staining on primary lesion fulfills all the criteria above;(6)The following patients whose type of surgery is likely to improve with use of preoperative treatment; (a) patients who are eligible for partial mastectomy but are considered to have problems with risks of positive margins or cosmetics, (b) patients considered eligible for total mastectomy;(7)Patients whose Performance Status (PS) on ECOG is 0-1;(8)Patients whose major organ functions as follows are maintained; (a) white blood cell count is 3,000/mm3 or more or neutrophil count is 1,500/mm3 or more, (b) hemoglobin is 9.0g/dL or more, (c) platelet count is 100,000/mm3 or more, (d) AST/ALT is within 2.5 times the facility's upper limit of the normal, (e) total bilirubin is 1.5g/dL or less (f) normal electrocardiogram (patients without cardiac diseases or severe arrhythmia); (9)Patients who have given written consent.
Key exclusion criteria	Exclusion criteria (1)Patients already receiving breast cancer treatment either with chemotherapy or endocrine therapy; (2)Patients who have a history of breast cancer. However, a patient can be considered eligible if the patient has metachronous bilateral breast cancer and it has been 10 years or more since the patient underwent surgery for contralateral breast cancer; (3)Patients who have active multiple primary cancer; (4)Patients who should receive surgery, chemotherapy or molecular targeted therapy instead of endocrine therapy as first line treatment; (5)Besides the above, patients that are considered ineligible by the principal investigator.
Target sample size	60

Research contact person
Name of lead principal investigator	Takei Hiroyuki
Organization	Saitama Cancer Center
Division name	Breast surgery
Address	818 Ooaza Komuro, Inamachi, Kitaadachi-gun, Saitama, Japan 362-0806
TEL	048-722-1111
Email

Public contact
Name of contact person	Kai Toshihiro
Organization	NPO Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name	Shintoshin Ladies' Mammo Clinic
Address	3F Capital Building 4-261-1 Kishikicho, Oomiya-ku, Saitama-shi, Saitama, Japan 330-0843
TEL	048-600-1722
Homepage URL	http://www.sbccsg.org/
Email	h-takei@cancer-c.pref.saitama.jp

Sponsor
Institute	NPO Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department

Funding Source
Organization	NPO Saitama Breast Cancer Clinical Study Group (SBCCSG)
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	埼玉県立がんセンター（埼玉県）、　さいたま赤十字病院（埼玉県）、　自治医科大学附属大宮医療センター（埼玉県）、　埼玉社会保険病院（埼玉県）、赤心堂病院（埼玉県）など

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 03 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 09 Month 30 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2018 Year 09 Month 01 Day
Date of closure to data entry	2018 Year 09 Month 01 Day
Date trial data considered complete	2018 Year 09 Month 01 Day
Date analysis concluded	2018 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	SBCCSG-03(Preoperative Exemestane administration phase II trail):the pathological response rate was 43%, the clinical response rate was 66%, the breast conservation rate was 90%, and each adverse event (most being Grade 1) was 10% or less. SBCCSG-10(Phase II trial to clarify the optimal duration to achieve maximum response with preoperative endocrine therapy):Of the 24 cases that were eligible, 22 responded and the median time to progression was 13.8 months and the maximum response duration was 6.4 months; thus, the optimal duration is considered to be 6 months.

Management information
Registered date	2011 Year 10 Month 02 Day
Last modified on	2017 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007658