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

UMIN ID: C000000345

Registered date:06/03/2006

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Breast Cancer
• Date of first enrollment: 2006/03/01
• Target sample size: 110
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Preoperative treatment with Exemestane 25mg/day for 24 weeks.

Outcome(s)

Primary Outcome

Determine the clinical response rate.
Determine the incidence of adverse events.

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: 55years-old
• Age maximum: 79years-old
• Gender: Female

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Japanese Foundation for Multidisciplinary Treatment of Cancer
• Source(s) of Monetary Support: Japanese Foundation for Multidisciplinary Treatment of Cancer