UMIN-CTR Clinical Trial

Public title

Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-23)

Acronym

Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-23)

Scientific Title

Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-23)

Scientific Title:Acronym

Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-23)

Region

Japan

Condition

Breast cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Takei Hiroyuki

Organization

Saitama Cancer Center

Division name

Breast surgery

Zip code

Address

818 Ooaza Komuro, Inamachi, Kitaadachi-gun, Saitama, Japan 362-0806

TEL

048-722-1111

Email

Name of contact person

1st name
Middle name
Last name	Kai Toshihiro

Organization

NPO Saitama Breast Cancer Clinical Study Group (SBCCSG)

Division name

Shintoshin Ladies' Mammo Clinic

Zip code

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

Institute

NPO Saitama Breast Cancer Clinical Study Group (SBCCSG)

Institute

Department

Personal name

Organization

NPO Saitama Breast Cancer Clinical Study Group (SBCCSG)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2011

Year

10

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2011

Year

09

Month

30

Day

Date of IRB

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

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.

Registered date

2011

Year

10

Month

02

Day

Last modified on

2017

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007658