A Phase II study of intermittent letrozole plus transdermal estradiol gel 3 month-therapy as adjuvant endocrine treatment for postmenopausal women with hormone-receptor positive early stage breast cancer.

ISTITUTO EUROPEO DI ONCOLOGIA0 个研究点开始时间: 2012年9月25日最近更新: 2014年2月10日

适应症

试验速览

暂无简介。

•Postmenopausal women with operable breast cancer
•- Patient with diagnosis of histological proven breast cancer (pT1, pT2, or pT3, N sentinel negative, pN0(either i- or i+); M0.
•- Diagnosis of hormone receptor positive tumors. (ER and/or PgR must be greater than or equal to 10%)
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 26

•Patients who are premenopausal
•- Patients with locally advanced disease (pN1, pN2, pN3) or distant metastatic disease
•- Patients with bilateral invasive breast cancer
•- Patients with positive final margins (referring to only DCIS and invasive cancer, not LCIS).
•- Patients with a history of prior ipsilateral or contralateral invasive breast cancer.
•- Patients with previous or concomitant malignancy EXCEPT adequately treated (basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma).
•- Patients who have received prior therapy for breast cancer including prior irradiation, adjuvant or neoadjuvant chemotherapy or endocrine therapy.
•- Patients who were taking tamoxifen or other SERM (e.g. Raloxifene) or hormone replacement therapy (HRT) within one year prior to their breast cancer diagnosis.

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