A Phase II study evaluating intermittent letrozole as adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, early stage breast cancer - ND

ISTITUTO EUROPEO DI ONCOLOGIA0 个研究点开始时间: 2007年8月1日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Compliant postmenopausal women with operable breast cancer
•- Patients with histologic diagnosis of invasive breast cancer (pT1, pT2, or pT3, Nsentinelnegative, pN0(either i- or i+); M0.
•- Patients must have hormone receptor positive tumors properly treated by surgery.
•- Written informed consent
•- Patients must be accessible for follow-up.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- 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 with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent prolonged follow-up. Patients with previous thrombosis (e.g., DVT) and/or embolism can be included only if medically suitable.
•- Patients who received neoadjuvant 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.
•- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.

发起方