Clinical study for postmenopausal patients with early breast cancer treated with letrozole for 5 years and withdrawal of 3 months plus transdermal estrogen therapy.

• Conditions: Breast cancer; MedDRA version: 14.1Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-001978-28-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-25
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

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

Inclusion Criteria

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

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 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.

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 increase (a 50% increase) in serum Estradiol levels after 3-month estradiol treatment.;Secondary Objective: •To evaluate patient-reported outcomes (PRO) in terms of symptoms related to endocrine treatment and two global quality of life (QoL) indicators.<br>•To evaluate the change in the biochemical marker of bone turnover modification C-telopeptide (C-terminal telopeptide of the 1 chain of type I collagen (CTX)), after 3-month estradiol treatment. <br>•To evaluate breast cancer related free survival (BCRS), disease free survival (DFS), and overall survival (OS). <br>•To compare the results of this study to the results of our previous study on 3-month letrozole therapy free interval.;Primary end point(s): serum Estradiol levels after 3-month estradiol treatment.;Timepoint(s) of evaluation of this end point: at baseline and after 3 months of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •patient-reported outcomes (PRO) in terms of symptoms related to endocrine treatment and two global quality of life (QoL) indicators.<br>•variations of biochemical marker of bone turnover modification C-telopeptide (C-terminal telopeptide of the 1 chain of type I collagen (CTX)), after 3-month estradiol treatment. <br>•breast cancer related free survival (BCRS), disease free survival (DFS), and overall survival (OS).;Timepoint(s) of evaluation of this end point: For Quality of Life: 24 months<br>For C-tepoleptide marker evaluation: 15 months<br>For BCRS, DFS, OS evaluation: ongoing