NIPH Clinical Trials Search

UMIN ID: C000000345

Registered date:06/03/2006

Phase II study of neoadjuvant treatment with Exemestane for 24 weeks in postmenopausal women with hormone receptor positive Stage II or IIIA breast cancer.

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedBreast Cancer
Date of first enrollment2006/03/01
Target sample size110
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Preoperative treatment with Exemestane 25mg/day for 24 weeks.


Primary OutcomeDetermine the clinical response rate. Determine the incidence of adverse events.
Secondary OutcomeDetermine 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.

Key inclusion & exclusion criteria

Age minimum55years-old
Age maximum79years-old
Include criteria1) 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
Exclude criteria1) 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.

Related Information


public contact
Name Japanese Foundation for Multidisciplinary Treatment of Cancer
Address TaniBuilding3F, 1-28-6, kameido, koutou-ku, Tokyo, 136-0071, Japan Japan
Telephone 03-5627-7594
Affiliation Japanese Foundation for Multidisciplinary Treatment of Cancer Office
scientific contact
Name Masakazu Toi
Address 54 Shogoin-Kawaramachi, Sakyo-ku, Kyoto 606-8507, Japan Japan
Telephone 075-751-3660
Affiliation Graduate School of Medicine, Kyoto University Department of Surgery (Breast Surgery)