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

Overview

No summary available.

Registry

who.int

Start Date

August 1, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•\- 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

•\- 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.