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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000345 |
Receipt No. | R000000443 |
Scientific Title | Phase II study of neoadjuvant treatment with Exemestane for 24 weeks in postmenopausal women with hormone receptor positive Stage II or IIIA breast cancer. |
Date of disclosure of the study information | 2006/03/06 |
Last modified on | 2019/03/18 |
Basic information | ||
Public title | Phase II study of neoadjuvant treatment with Exemestane for 24 weeks in postmenopausal women with hormone receptor positive Stage II or IIIA breast cancer. | |
Acronym | Neoadjuvant Exemestane for 24 weeks in postmenopausal Women with hormone receptor positive Stage II or IIIA breast cancer (JFMC34-0601) | |
Scientific Title | Phase II study of neoadjuvant treatment with Exemestane for 24 weeks in postmenopausal women with hormone receptor positive Stage II or IIIA breast cancer. | |
Scientific Title:Acronym | Neoadjuvant Exemestane for 24 weeks in postmenopausal Women with hormone receptor positive Stage II or IIIA breast cancer (JFMC34-0601) | |
Region |
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Condition | |||
Condition | Breast Cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Examine the clinical response and safety of neoadjuvant therapy with Exemestane for 24 weeks in postmenopausal women with hormone receptor positive Stage II or IIIA breast cancer. As secondary object, develop a predictive model of response and long term outcomes based on gene expression and proteomics profiling. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Determine the clinical response rate.
Determine the incidence of adverse events. |
Key secondary outcomes | Determine the long-term outcomes (overall survival, relapse free survival).
Determine the rate of improvement in surgical outcomes (breast conserving rate, local recurrence rate). Determine the rate of axillary lymph node involvement and pathologic response. Examine the change of biomarker (e.g., Ki-67, TUNEL, bcl-2, M-30) with this treatment. Develop a predictive model of response and long term outcomes based on gene expression and proteomics profiling. |
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 |
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Interventions/Control_1 | Preoperative treatment with Exemestane 25mg/day for 24 weeks. | |
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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 1) Histologically confirmed invasive breast cancer excluding mucinous and lobular cancer by core needle biopsy or open biopsy.
2) Clinical stage T2-T3, N0-2, M0. 3) Estrogen- and/or Progesterone-receptor positive tumor based on 10% or more nuclear staining of the invasive ductal component by immunohistochemistry. 4) Her2 expression was examined by IHC and/or FISH. 5) Previously untreated disease. 6) WHO performance status 0-1. 7) Expecting benefits from neoadjuvant therapy that would improve surgical outcome and meets criteria for 1 of the following: (a) Marginal candidate for lumpectomy (e.g., lumpectomy feasible but patient at risk for positive margins or poor cosmetic outcome). (b) Ineligible for lumpectomy, but modified radical mastectomy feasible. 8) Sentinel lymph node biopsy allowed before treatment or after treatment. 9) Patients must be age between 55 y.o. to 79 y.o. and postmenopausal verified by one of the following. (a) amenorrhea more than 1 year (b) artificial menopause by radiation or bilateral ovariectomy (c) FSH >= 30mIU/ml and E2 < 10pg/ml 10) Willing and able to provide biopsy materials and blood samples for research purpose. 11) No severe liver dysfunction. 12) Confirmed by attending doctor as a candidate for this trial after consideration of other treatment options. 13) Written informed consent |
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Key exclusion criteria | 1) Concurrent user of HRT, raloxifen and other sex hormone related drugs.
2) Patients with bilateral breast cancer, past history of breast cancer and active other type of cancer. 3) Absolute candidate for primary chemotherapy or surgery. |
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Target sample size | 110 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Graduate School of Medicine, Kyoto University | ||||||
Division name | Department of Surgery (Breast Surgery) | ||||||
Zip code | |||||||
Address | 54 Shogoin-Kawaramachi, Sakyo-ku, Kyoto 606-8507, Japan | ||||||
TEL | 075-751-3660 | ||||||
toi@kuhp.kyoto-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Japanese Foundation for Multidisciplinary Treatment of Cancer | ||||||
Division name | Office | ||||||
Zip code | |||||||
Address | TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan | ||||||
TEL | 03-5627-7594 | ||||||
Homepage URL | http://www.jfmc.or.jp/ | ||||||
jfmc-dc@jfmc.or.jp |
Sponsor | |
Institute | Japanese Foundation for Multidisciplinary Treatment of Cancer |
Institute | |
Department |
Funding Source | |
Organization | Japanese Foundation for Multidisciplinary Treatment of Cancer |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization | Japan |
Other related organizations | |
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IRB Contact (For public release) | |
Organization | |
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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 | 札幌医科大学 第一外科(北海道)、岩手医科大学 外科(岩手)、福島県立医科大学 第二外科(福島)、筑波大学 乳腺甲状腺内分泌外科(茨城)、群馬県立がんセンター 乳腺科(群馬)、埼玉医科大学国際医療センター 乳腺腫瘍科(埼玉)、埼玉県立がんセンター 乳腺外科(埼玉)、東京都立駒込病院 外科(東京)、順天堂大学医学部附属練馬病院 乳腺外科(東京)、昭和大学病院 一般・消化器外科(東京)、東邦大学医療センター大森病院 乳腺・内分泌外科(東京)、東京医科大学 乳腺科(東京)、国立国際医療センター 外科(東京)、東京女子医科大学 東医療センター 外科(東京)、癌研究会有明病院 化学療法科(東京)、日本大学医学部附属板橋病院 乳腺内分泌外科(東京)、東京都立府中病院 外科(東京)、三井記念病院 乳腺内分泌外科(東京)、聖路加国際病院 乳腺外科(東京)、国際医療福祉大学三田病院 乳腺センター (東京)、神奈川県立がんセンター 乳腺甲状腺外科(神奈川)、東海大学医学部 乳腺内分泌外科(神奈川)、信州大学医学部附属病院 乳腺内分泌外科(長野)、新潟県立がんセンター新潟病院 外科(新潟)、藤田保健衛生大学病院 乳腺外科(愛知)、愛知県がんセンター中央病院 乳腺科(愛知)、名古屋市立大学病院 乳腺内分泌外科(愛知)、京都大学 乳腺外科(京都)、国立病院機構大阪医療センター 外科(大阪)、関西労災病院 外科(大阪)、広島市立安佐市民病院 外科(広島)、国立病院機構四国がんセンター 乳腺科(愛媛)、北九州市立医療センター 外科(福岡)、国立病院機構九州がんセンター 乳腺科(福岡)、医療法人にゅうわ会及川病院 外科・乳腺腫瘍科(福岡)、熊本大学医学部附属病院 乳腺・内分泌外科(熊本)、熊本市立熊本市民病院 乳腺内分泌外科(熊本) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | http://www.jfmc.or.jp/wp-content/uploads/2015/01/jfmc34-0601_070117.pdf |
Publication of results | Partially published |
Result | |||||||
URL related to results and publications | https://doi.org/10.1111/j.1349-7006.2011.01867.x | ||||||
Number of participants that the trial has enrolled | 116 | ||||||
Results | Between March 2006 and December 2007, 116 patients were enrolled. Among those, 102 patients completed 24 weeks administration. The ORR was 47% (55/116) at week 16 and 51% (59/116) at week 24, respectively. No serious toxicity was seen. At diagnosis, 59 patients (51%) would have required mastectomy but 40 patients were converted to BCS, showing an increase in the rate of BCS (77%). The 24-week aromatase inhibition provided preferable clinical benefits with significant reduction in Ki67 index. | ||||||
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Baseline Characteristics | Between March 2006 and December 2007 a total of 116 patients were enrolled. T2 stage were 110 cases and N0 were 91 cases. All patients were defined as ER-positive, 80 (68.9%) were PgR-positive and 3(2.5%) were HER2-positive by investigator evaluation. | ||||||
Participant flow | During the first 16 weeks, 10 patients discontinued neoadjuvant exemestane treatment because of PD (4 patients), investigator decision (1 patient), adverse events (2 patients, 1 of whom was not evaluable at Week 16), or patients decision (3 patients, 2 of whom were not evaluable at Week 16). 102 patients completed 24 weeks of exemestane neoadjuvant treatment. | ||||||
Adverse events | The most frequently seen adverse events were an abnormal increase in liver enzyme levels (SGOT, SGPT and ALP), hot flush, joint pain, hypoalbuminuria and elevated creatinine and bilirubin levels. None of these adverse events were deemed to be severe in intensity. The only Grade 3 adverse events were elevated liver enzymes in four cases. | ||||||
Outcome measures | The primary end points were objective response rates (ORR) and safety after 16 and 24 weeks of treatment in intent to treatment analysis. | ||||||
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Recruitment status | Completed | ||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000443 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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