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

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10057654Term: Breast cancer female; hormone receptor positive breast cancer

• Registration Number: EUCTR2007-002059-18-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the biological impact in terms of increase in serum Estradiol levels after 3-month Letrozole treatment free interval at the end of 1st year of continue letrozole;Secondary Objective: to evaluate markers of endocrine, lipid and bone metabolism;Primary end point(s): increase of estradiol levels after 3 months interval free of treatment