Unique ID issued by UMIN | UMIN000004752 |
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Receipt number | 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 | 2021/07/08 10:47:57 |
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)
JBCRG-11TC
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)
JBCRG-11TC
Japan |
ER positive, HER2 negative, Stage II or IIIA [T2-3,N0-2,M0], Primary Postmenopausal Invasive Breast Cancer Patients
Hematology and clinical oncology | Surgery in general | Breast surgery |
Malignancy
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Clinical response at Week 24 and Week 36
(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
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
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.
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.
Not applicable |
65 | years-old | > |
Female
(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
(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
60
1st name | Nobuaki |
Middle name | |
Last name | Sato |
Niigata Cancer Center Hospital
Department of Surgery
951-8566
2-15-3 Chuo-Ku, Kawagishi-cho
025-266-5111
nobus@niigata-cc.jp
1st name | Jun |
Middle name | |
Last name | Fukase |
Japan Breast Cancer Research Group (JBCRG)
Head Office
103-0016
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
03-6264-8873
https://www.jbcrg.jp/
office@jbcrg.jp
Japan Breast Cancer Research Group (JBCRG)
Japan Breast Cancer Research Group (JBCRG)
Self funding
Japan
N/A
N/A
N/A
N/A
NO
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)
2010 | Year | 12 | Month | 20 | Day |
Published
https ://doi.org/10.1002/cam4.2423
58
Results
Clinical response rates at 8-12 and 24 weeks were 71% and 57%, respectively, in group A, and 16% and 56%, respectively, in group B.
Conclusions
The tailored treatment maintained the favorable clinical response to exemestane alone in responders and improved clinical response in nonresponders.
2021 | Year | 07 | Month | 01 | Day |
2019 | Year | 09 | Month | 16 | Day |
Untreated postmenopausal patients with primary invasive ER-positive, HER2-negative, stage I-IIIA
(T1c-T3, N0-2, M0) breast cancer.
Patients initially received exemestane for 12 weeks.
For the subsequent 12 weeks, exemestane monotherapy was continued for responders (group A), whereas nonresponders received exemestane plus four cycles of TC (group B).
Adverse events grade 3 and 4 were reported in 40% of patients (group A, 8%; group B, 53%). The most common were leukopenia (37%), neutropenia (32%), and febrile neutropenia (16%) during chemotherapy (group B).
Clinical response rate, defined as the proportion of patients with either CR or PR, at 24 weeks was the primary end point.
Completed
2010 | Year | 10 | Month | 29 | Day |
2010 | Year | 11 | Month | 22 | Day |
2010 | Year | 11 | Month | 23 | Day |
2026 | Year | 03 | Month | 31 | Day |
2010 | Year | 12 | Month | 18 | Day |
2021 | Year | 07 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005613
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