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

Japanese Foundation for Multidisciplinary Treatment of Cancer0 个研究点目标入组 110 人开始时间: 2006年3月6日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

•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.

发起方

Japanese Foundation for Multidisciplinary Treatment of Cancer